Pharmaceuticals & Biotech

Stock Market Trends: Dangers of Small Biotechs- A lot of people bet large amounts of money on small biotechs that have one or two promising drugs in trials, hoping to cash in big when that drug becomes a blockbuster. More often than not, they lose their shirts when the FDA gets in the way of their dreams. This is what happened today [...]
A BIOTECH BLOOM IN JULY. (IBB, BBH, XBI, DNA, AMGN, OSIP, ONXX, CELG, GILD, IMCL, VRTX, CMED, AUXL, ACOR, SVNT, SQNM, MDVN, GT- Submitted By Optiondragon and Biotechman Fast-Tracking Cancer Drugs (CBS News) The best performing sector in the past month has been biotech. With investors flocking to safety due to recent financial turmoil and the sharp correction in energy, funds and investors have been warming up to biotech. The biotech sector is not without its large risks [...]
C5 "Biotech Patenting" Conference, London, September 23-24- C5 will be bringing its popular "Biotech Patenting" conference to London on September 23-24. According to C5, the conference "provides updates on the latest developments in biotech patenting, including recent case law and regulatory developments." The conference is unique in...
FDA Calendar: 2H08 Dates-

Medicines Co. MDCO 7/24/08 -->sNDA Angiomax

Vanda/Titan Pharm VNDA/TTP 7/27/08 -->iloperidone NDA

CV Therapeutics CVTX 7/27/08 -->Ranexa sNDA

MGi Pharma MOGN 7/27/08 -->Aquavan NDA

Gilead GILD 8/11/08 -->Viread sNDA

Gilead GILD 9/16/08 -->aztreonam lysine NDA

Mentor MNT 9/30/08 -->Puragen Plus 510(k) PMA
Federal Circuit Affirms Acular LS Decision in Favor of Roche and Allergan, and Against Apotex-
Roche Palo Alto and Allergan v. Apotex, No. 2008-1021 (Fed. Cir. 2008)

In an opinion released today , the Federal Circuit affirmed a district court decision granting summary judgment that Roche's U.S. Patent No. 5,110,493 is valid and infringed by Apotex's ANDA for a generic version of Acular LS (ketorolac tromethamine opthalmic solution). Acular LS, marketed by Allergan, is indicated to reduce pain, burning and stinging following corneal refractive surgery.
Book Review: Generic Pharmaceutical Patent and FDA Law-
Shashank Upadhye has written a new text, Generic Pharmaceutical Patent and FDA Law, that anyone reading Orange Book Blog will certainly find useful. Mr. Upadhye is Vice President & Global Head of Intellectual Property for Apotex.

The book provides a nice overview of patent law--especially as applied to pharmaceuticals--and the drug approval process. In addition, it includes detailed chapters on issues that arise from the Hatch-Waxman Act, including Orange Book patent certifications and notice letters, the 30-month stay, 180-day exclusivity and forfeiture, and declaratory judgment. A complete list of the book's chapters appears below.

On June 25, the Congressional Budget Office released a cost estimate for the Biologics Price Competition and Innovation Act of 2007 (S. 1695), concluding that the biosimilars bill would save American consumers $25 billion on prescription drug costs over the next ten years. For more: statements from BIO and PhRMA; FDA Legislative Watch; Pharmalot; The Hill's Congress Blog.
In a "Surprising" Victory, Barr and Mylan Invalidate Boehringer Ingelheim's Patent on Mirapex-
Boehringer Ingelheim v. Barr and Mylan, No. 05-700-JJF (D. Del. 2008)

Last week, following a bench trial held in March, the U.S. District Court for the District of Delaware held that Boehringer Ingelheim's patent on Mirapex (pramipexole dihydrochloride) is invalid for obviousness-type double patenting. Mirapex, indicated for the treatment of Parkinson's disease and Restless Leg Syndrome, has annual U.S. sales of approximately $380 million.
Mylan Prevails Over AstraZeneca in Appeal of Prilosec Case-
In re Omeprazole Patent Litigation, Nos. 2007-1476, -1477, -1478 (Fed. Cir. 2008)

Yesterday, the Court of Appeals for the Federal Circuit affirmed a June 2007 district court decision finding that Mylan's generic version of Prilosec (omeprazole) does not infringe two AstraZeneca patents, U.S. Patent Nos. 4,786,505 and 4,853,230.
Federal Circuit Affirms Lovenox Decision-
Aventis Pharma v. Amphastar and Teva, No. 2007-1280 (Fed. Cir. 2008)

Today's opinion

Previous post

More later...

As reported by FDA Law Blog, FDA determined on May 7 that Cobalt forfeited its 180-day exclusivity on acarbose and Cobalt sued FDA on May 8 for injunctive relief. Last Friday, for some reason, Cobalt voluntarily dismissed its suit against FDA.
Also last Friday, FDA appealed the D.C. district court's decision requiring relisting of Janssen's patent on Risperdal (risperidone).

The Federal Trade Commission announced the release of its FY 2007 Summary of Pharmaceutical Company Settlement Agreements. For commentary, see FDA Law Blog, Pharmalot.
Wyeth sued Sandoz over a generic version of Protonix I.V. The WSJ Health Blog recapped all the Protonix ANDA litigation.
India's drugmakers recently threatened to stop production of 33 bulk drugs, Pharmalot reports.
The Washington Legal Foundation announced that it filed an amicus brief urging the Federal Circuit to rehear the Caraco v. Forest Labs case.
Archived Reports- Check out my new page of archived stock research reports and commentaries at After Court Victory over FDA, Teva Receives Final Approval of Risperidone ANDA and Launches With 180-Day Exclusivity-
Teva announced yesterday that the FDA granted final approval to its ANDA for generic Risperdal (risperidone) tablets, that it was awarded 180-day exclusivity as the first paragraph IV filer for risperidone, and that it immediately commenced a commercial launch. FDA confirmed the final approval in a press release. Risperdal is a schizophrenia drug marketed by Janssen, a unit of Johnson & Johnson, with annual U.S. sales of $2.8 billion.
Mutual Pharmaceutical Jumps the Gun By Sending Paragraph IV Notice Letter Before Acceptance of ANDA-
GlaxoSmithKline v. Mutual Pharm., No. 08-549 (E.D. Pa. 2008)

The U.S. District Court for the Eastern District of Pennsylvania recently granted a motion for judgment on the pleadings in a paragraph IV case because the ANDA filer sent its notice letter prematurely, before FDA had accepted the ANDA for filing. The case concerns Mutual Pharmaceutical's generic version of GlaxoSmithKline's heart medication Coreg CR (carvedilol phosphate).
FDA Denies King Pharma's Citizen Petition Concerning Altace, Approves Ramipril ANDAs-
We reported last month that King Pharmaceuticals filed a citizen petition that could delay final approval of numerous ANDAs for generic versions of Altace (ramipril), which were set to earn final approval on June 7. King's citizen petition asked FDA to require ANDA applicants for ramipril to file patent certifications with respect to newly-issued U.S. Patent No. 7,368,469, a method-of-use patent.

On June 18, FDA denied King's citizen petition, concluding that the ANDAs may be approved with section viii "carve out" statements and that patent certifications are not necessary. The same day, FDA granted final approval to the ANDAs.

FDA's letter decision explains that King sought for FDA to
C5 "Pharma Patent Lifecycles" Conference, London, June 26-27-
C5 will be holding a "Pharma Patent Lifecycles" conference June 26-27 in London. According to C5, "since 2001, thousands of life sciences patent professionals have made C5's Pharma Patent Lifecycles conferences their source of information for the most up-to-date legal developments surrounding patent lifecycle management."

The agenda includes numerous presentations that may be of interest to readers:
King Pharmaceuticals Files Citizen Petition Relating to New Patent on Altace (Ramipril)-
King Pharmaceuticals markets Altace (ramipril), which is indicated for the treatment of high blood pressure. Until last year, when the Federal Circuit invalidated King's compound patent on ramipril, King earned about $700 million annually from U.S. sales of Altace.

Although Lupin was the ANDA filer who prevailed against King in the patent litigation, Cobalt Labs, as the first ANDA filer, won the 180-day exclusivity rights. In a letter dated January 29, 2008, to attorneys for Lupin, FDA explained that Cobalt's exclusivity was triggered on December 10, 2007, and will expire on June 7, 2008.
IIR "Generic Drugs Summit," Washington, D.C., June 18-20-
The Institute for International Research will be holding its 9th annual "Generic Drugs Summit," June 18-20 in Washington, D.C.

According to IIR, this is "the leading independent forum addressing business and legal concerns impacting the generics marketplace. This event attracts 200+ senior-level professionals representing government, regulatory and legal affairs as well as marketing, sales and business development."

The agenda on June 19-20 includes many interesting presentations:
GPhA Files Amicus Brief in Appeal of "Baseless Paragraph IV Certification" Case; Warns of Chilling Effect on Future Patent Chall-
Takeda v. Mylan and Alphapharm, Nos. 2007-1269, -1270 (Fed. Cir.)

In February 2006, the U.S. District Court for the Southern District of New York determined that Takeda's patent on pioglitazone, the active ingredient in ACTOS, is neither invalid for obviousness nor unenforceable due to inequitable conduct. In the court's 124-page opinion, the court remarked, "The length of this Opinion is occasioned by the need to address the many iterations of the defendants' arguments, as they searched for a viable theory to attack the '777 patent."
ACI "In-House Counsel Forum on Pharmaceutical Antitrust," National Harbor, Maryland, May 20-21-
American Conference Institute will be holding its fourth annual "Pharmaceutical Antitrust" conference in National Harbor, Maryland, on May 20-21.

According to ACI, at the conference, "leading in-house pharmaceutical counsel, government regulators, and expert attorneys will provide practical advice on how to successfully tackle the most complex antitrust issues facing brand-name and generic pharmaceutical companies."

Several of the presentations look particularly interesting:
Barr and Caraco Win Summary Judgment that Ortho-McNeil's Formulation Patent on Ultracet is Invalid-
Ortho-McNeil Pharm. v. Kali Labs., No. 06-CV-3533 (DMC)

by Robert S. Dailey

In a decision released April 17th, the U.S. District Court for the District of New Jersey granted summary judgment that certain claims of U.S. Patent No. RE39,221 are invalid as obvious. The '221 patent claims combinations of acetaminophen and tramadol, marketed by Ortho-McNeil (OMI) as Ultracet. Barr and Caraco are challenging the patent.
Apotex Sues FDA to Recover 180-Day Exclusivity on Generic Plavix-
In November 2001, Apotex became the first company to file an ANDA for a generic version of Plavix (clopidogrel bisulfate) with a paragraph IV certification. In March 2002, Sanofi-Synthelabo and Bristol-Myers Squibb sued Apotex for infringing the Orange Book-listed patent, U.S. Patent No. 4,847,265, thereby initiating an automatic 30-month stay of FDA approval of Apotex's ANDA.
ACI "Paragraph IV Disputes" Conference, New York City, April 30-May 1-
American Conference Institute will be holding its 2nd annual "Paragraph IV Disputes" conference in New York City next week, April 30 to May 1. This should be an excellent meeting, with many great speakers on the agenda.

Specific talks of interest include the following:
Informa Life Sciences "EU Pharmaceutical Law Forum," Brussels, Belgium, May 8-9-
Informa Life Sciences will be holding its 17th annual "EU Pharmaceutical Law Forum" in Brussels, Belgium, on May 8 and 9. This conference is billed as the "must attend" meeting for in-house counsel in pharmaceutical companies and lawyers in private practice who specialize in the life sciences. Speakers will examine in detail the recent developments in trade, competition, intellectual property and regulatory matters of concern to the pharmaceutical industry.

Conference highlights include:
Federal Circuit Refuses to Rehear Caraco v. Forest- We previously reported that on April 1, in a 2-1 decision in Caraco v. Forest, the Federal Circuit held that an ANDA applicant may in some circumstances bring a declaratory judgment action for noninfringement even if the patentee has granted...
Patent Litigation Under a Future Biosimilars Act-
Biopharmaceuticals, such as Epogen® (epoetin) and Erbitux® (cetuximab), are becoming increasingly important for the treatment of disease. U.S. sales of such drugs were about $40 billion in 2006 and are expected to rise to over $90 billion in 2009. Accordingly, political pressure is building to allow the sale of “biosimilar” drugs. Inspired by the success of the Hatch-Waxman Act, which has led to the wide use of generic “small molecule” drugs, four different biosimilars bills have been introduced in Congress in the past fifteen months. Three of the proposed bills would establish a complex scheme for patent litigation between brand-name and generic biopharmaceutical companies, especially as compared to the Hatch-Waxman Act.

Hatch-Waxman Act
ACI "FDA Boot Camp" Conference, San Francisco, May 29-30- American Conference Institute's very popular "FDA Boot Camp" returns to San Francisco later this month, May 29-30. The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of...
WBR "PharmaBiotech IP Summit," Philadelphia, May 28-30- Worldwide Business Research will be holding a conference entitled "PharmaBiotech IP Summit," May 28-30 at the Ritz-Carlton in Philadelphia. According to WBR, "the event balances the challenges of IP protection, enforcement and management, providing both strategic and actionable insights through...
District Court Upholds Validity of Takeda's Patents on Prevacid, Rejecting Teva's Obviousness Arguments- Takeda Pharma. v. Teva Pharms. USA, No. 06-033-SLR (D. Del. 2008) Following a week-long bench trial held last year, the U.S. District Court for the District of Delaware released an opinion on March 31st stating that Takeda's patents on Prevacid...
District Court Upholds Validity of P&G's Actonel Patent, Rejecting Teva's Obviousness Arguments-
Proctor & Gamble v. Teva Pharms. USA, No. 04-940 (D. Del. 2008)

Late last month, the U.S. District Court for the District of Delaware (J. Farnan) upheld the validity of Proctor & Gamble's U.S. Patent No. 5,583,122, which claims risedronate sodium, the active ingredient in Actonel. Teva had challenged the '122 patent in a paragraph IV certification in its ANDA. P&G's U.S. sales of Actonel, which is indicated for the prevention and treatment of osteoporosis, were approximately $1 billion last year.
Federal Trade Commission Files Amicus Brief in Ciprofloxacin "Reverse Payment" Case- The Federal Trade Commission announced last week that it recently filed an amicus brief in In re Ciprofloxacin Hydrochloride Antitrust Litigation, currently pending in the Federal Circuit. In the case, direct purchaser plaintiffs of Cipro (ciprofloxacin) alleged that settlements of...
FDA Answers Ramipril Letters, Explains Why Cobalt Has 180-Day Exclusivity- As we reported last November, the Federal Circuit's decision invalidating U.S. Patent No. 5,061,722 on Altace (ramipril) was followed by a flood of letters to FDA concerning 180-day exclusivity for ramipril. Although Cobalt was the first to file a ramipril...
A New Way for Investors to Ride the Rails-
Last week, Warren Buffett’s Berkshire (BRK-A) announced that it raised its investment stake to 18.2% in the second largest domestic railroad, Burlington Northern Santa Fe (BNI). At Berkshire’s annual meeting last year, Buffett and vice chairman Charlie Munger discussed their investment interest in railroads since the industry is healthier today compared to past years.

Rochester Medical Rises Ahead of Trial Date-

Shares of small-cap medical device maker Rochester Medical (Nasdaq: ROCM) have moved up over 25% this week, currently trading at just over $14 per share. The rise occurs ahead of a scheduled trial date with medical products giant and Tyco (NYSE: TYC) spin-off Covidien (NYSE: COV) that is scheduled for the end of February.

Cytori Therapeutics (CYTX): A Buy Around 5 Bucks- Shares of Cytori Therapeutics (CYTX) are currently a strong buy around the $5 level, ahead of near-term commercialization of its adult-derived adipose stem cell banking in Japan (StemSource) and breast reconstruction applications (Celution System) in Europe. Cytori has traded in a sawtooth pattern over the last 52 weeks with reliable bounces from the $5 level to over $6 on several previous occasions. Despite concerns by some investors over a possible stock offering to shore up the balance sheet, I believe this can be avoided.

Baby Boomers: Invest with the Trend-

A significant demographic trend in the United States that can be applied to stock market investing is the aging of the Baby Boomers, which includes those born between 1946 to 1964. A demographic profile report by MetLife (MET) on this group estimates spending power in excess of $2 trillion, representing 26% of the American population.

A Recession Proof Stock Strategy-

Amidst the backdrop of an economic slowdown and a possible recession in the US, I have developed an exchange-traded fund (ETF) designed to provide investors with market-beating returns in any economic environment. The fund concentrates on stocks with market caps over $1 billion that are growth leaders in their businesses and focused on products and services that people need regardless of the economy.

IQPC "Pharmaceutical Patent Litigation Strategies 2008" Conference, London, March 31 - April 1- IQPC will be holding its 3rd annual "Pharmaceutical Patent Litigation Strategies" conference in London, March 31 to April 1. The conference is split into two days--one focusing on European law, the other focusing on U.S. law--and includes an optional third...

Tobacco as a Safe Haven & New ETF Idea-

The Return of Tobacco: Safe Haven in a Volatile Market

Teva Seeks Relisting of J&J's Risperdal Patent and Asserts Right to 180-Day Exclusivity- A reader recently e-mailed me about an interesting citizen petition that Teva filed last August. In the petition, Teva requests that FDA: (1) relist U.S. Patent No. 5,158,952 in the Orange Book for Risperdal (risperidone) tablets; (2) confirm Teva's right...

Good News for Dendreon, Bad News for Prostrate Cancer-

These days all eyes are on the state of the economy, not to mention the obsession with the financial sector. Maybe today is the day when we try to think about some of the other pressing matters that are important. Take as an example the good news announced todayfor Dendreon NASDAQ: (DNDN).

Insiders are Bullish on BioSante Pharma-

Since I last wrote about BioSante Pharma (BPAX) on Seeking Alpha in late September and issued a research report, the Company has executed on its o

AspenBio Pharma: Ready to Ascend New Heights-

Shares of AspenBio Pharma (APPY) are poised to ascend new heights during 2008 largely on the promise of the Company’s innovative blood screening test for appendicitis called AppyScore. In late October, AspenBio reached a high share price in the mid-teens after making a successful transition from bulletin board trading to the Nasdaq in late August.

RMTI is Poised to Emerge from Under the Radar of Investors-

In early December, Rockwell Medical Technologies (RMTI) received approval from the FDA to begin a NIH-sponsored clinical trial of its innovative, water soluble iron replacement therapy for dialysis patients called SFP for short (Soluble Ferric Pyrophosphate). The nine month, 30-patient, study will examine whether Rockwell’s SFP is able to support normal iron and hemoglobin levels, reduce the need for supplemental IV iron, and avoid causing oxidant stress and inflammation.

eHCi - New Top 10 Format as of 12/20/07-

Cytori Therapeutics (Nasdaq: CYTX) - report & update

VisICU (EICU) Acquired by Philips Today-

The first acquisition of a stock in my eHCi as Philips agreed to pay $12/share in cash for healthcare info tech provider/developer VisICU, representing an acquisition price of approximately USD 430 million (approximately EUR 290 million). Although the offer represents a nice 35% premium from yesterday's close, the $12/share offer is about one-half the initial trading levels after the Company's successful trading debut following its IPO.

NEJM Review on Radiation Exposure from CT scans-

Full text of article from NEJM at http://content.nejm.org/cgi/content/full/357/22/2277

The widespread use of CT represents probably the single mostimportant advance in diagnostic radiology.

CT Colongraphy (Virtual Colonoscopy)- Given recent NEJM review article and upcoming colorectal cancer screening guidelines, it appears widespread adoption and use of virtual colonoscopy is both unwarranted and unlikely to occur. Aside from the high cost of VC, patients must still undergo the same bowel prep and restrictions as with a normal colonscopy and if polyps are found during a VC then a follow-up colonoscopy will still be required. Also, flat lesions are likely to be missed by VC versus traditional colonoscopy.

A Biotech Triple Catalyst Play-

As 2007 winds down, investors in Genitope (GTOP) are keyed up for the final results of its experimental, personalized cancer immunotherapy treatment MyVax in the treatment of B-cell non-Hodgkin’s lymphoma. Results are expected some time this month, so the wait should not be much longer in what has been a long ride for the Company and its investors as two previously planned interim analyses failed to halt the trial early and demonstrate convincing effectiveness for MyVax.

A Super(Gen) Play on Cancer Biotech Consolidation-

SuperGen (SUPG) is a small-cap cancer biotech with a solid balance sheet, a history of regulatory success with a total of five approvals, and a rapid cancer drug discovery platform (CLIMB) with a pipeline that currently includes five compounds. Dacogen is licensed to MGI Pharma (MOGN) domestically and Johnson & Johnson (JNJ) outside of North America; while the Company closed a deal in April to sell the remaining worldwide rights to Hospira (HSP) for the cancer drug Nipent.

Pfizer Wins Dismissal of Ranbaxy's Counterclaims in Caduet Patent Litigation- Pfizer v. Ranbaxy, No. 07-138 (D. Del. 2007) Pfizer sued Ranbaxy for infringement of U.S. Patent Nos. 4,681,893 and 6,455,574 after Ranbaxy filed paragraph IV certifications in its ANDA for a generic version of Caduet (atorvastatin calcium/amlodipine besylate). The '893...

Pharma News Briefs- "Big Pharma Faces Grim Prognosis" was the first article on the front page of the Wall Street Journal Thursday. It proclaims: "Over the next few years, the pharmaceutical business will hit a wall." Summaries of the article appear on the...

EXACT Sciences (EXAS) Attractive After Recent Sell-Off- I like EXAS around the low-mid $3 level after a recent sell-off with no fundamental change in the Company's exponential upside potential as it awaits a response from the FDA on its proposed regulatory filing strategy & updated guidelines for colorectal cancer screening, which are expected to include its stool DNA-based test PreGen-Plus. Although guidelines were not released as previously indicated during November, professional GI orgs have not published anything that points to material delays in the revised guidelines.

District Court Upholds Validity of Pfizer's Accupril Patent, Rejecting Teva's Nonenablement Argument-

Warner-Lambert v. Teva Pharms. USA, No. 99-922 (D.N.J. 2007)

A Super Play on Cancer Biotech Consolidation-

Shares of SuperGen are a relatively low-risk play on consolidation among biotech companies specializing in cancer treatments. Survival data early next year for Dacogen should also provide a boost to SUPG, which has $1.40/share in cash with a share price of just $4.23 well of YTD highs and close to the low – making it a good risk-reward trade at this time.

SUPG stats (12/2/07):

Lovenox Patent Case Back at Federal Circuit; Generic Versions Still Not Yet Approved- Guest post by Robert S. Dailey

Sona Mobile (SNMB) at Racing & Gaming Symposium-

Come see us at The 2007 Symposium on Racing & Gaming, booth 50 for a demonstration of our server based gaming products including race & mobile wagering.

December 3-6, 2007 at the Westin La Paloma Resort in Tucson, Arizona.

Sona Mobile (SNMB) Closes Placement Ahead of Schedule- Sona Mobile Holdings Corp., a leading provider of secure software solutions for gaming and entertainment, announced today that it has closed its previously announced $3,000,000 private placement of convertible notes and warrants.

Dismissal of Invalidity Counterclaims Thwarts Apotex's Attempt to Trigger 180-Day Exclusivity on Cosopt-

Merck v. Apotex, No. 06-5789 (D.N.J. 2007)

A Bullish Diagnosis on Rochester Medical-

Rochester Medical Corporation (ROCM) develops and manufactures a line of urinary continence and urine drainage care products, which are marketed to hospitals and extended-care facilities. The Company's extended care products include a line of male external catheters for managing male urinary incontinence and a line of intermittent catheters for managing male and female urinary retention.

emerging Healthcare index (eHCi)-

The emerging Healthcare index (eHCi) was established on 11/24/07 at a starting value of $100.00 and average market cap of $200 million to track the performance of my Top 20 stock picks in the healthcare sector with market caps less than $750 million at the time of inclusion.

Short Seller Attack on BioSante??- Since making its debut on the Nasdaq on Monday 11/5/07, shares of BioSante Pharma (BPAX) appear to be under a short sale attack with increasing trading volumes and a move from the mid-upper $5's to the low-$4's with recent stabilization back into the upper-$4's today. Short sellers should be careful with BioSante now that it is has clarity from the FDA on LibiGel and is poised to begin key Phase 3 safety & efficacy trials in the near-term.

Pharma News Briefs- King Pharmaceuticals filed its 10-Q statement with the SEC on Friday, revealing that Cobalt Pharmaceuticals, the first ANDA filer for Altace (ramipril), recently notified King of its intent to launch its generic ramipril product, notwithstanding the settlement agreement between the...

Good News for Targeted Genetics (TGEN)- Targeted Genetics reported positive interim results for its experimental gene therapy treatment for inflammatory arthritis (tgAAC94) conditions at the 71st annual ACR annual meeting in a Saturday morning PR. More importantly, final molecular testing results confirmed preliminary testing, which demonstrated that tgAAC94 played no role in the patient death in this Phase 1/2 trial, which is currently on hold.

Solid Science at Cytori-

Adipose Stem & Regenerative Cells Not Linked to Arrhythmias in Preclinical Study; Important Safety Findings Published in EuroPace Cardiology Journal:

Journal Article #1 PDF

Journal Article #2 PDF

Journal Article #3 PDF

FDA's Request for Comments on Ramipril 180-day Exclusivity Draws Letters from Eight Generic Companies- King Pharmaceuticals markets Altace (ramipril), a treatment for high blood pressure with nearly $1 billion in annual U.S. sales. U.S. Patent No. 5,061,722, owned by Aventis and licensed to King, is listed in the Orange Book for Altace. In 2002,...

Pharma News Briefs- FDA recently posted numerous comments from industry regarding Ramipril 180-day exclusivity issues on its website. The comments come in response to FDA's request last month. A summary of the new comments is in the works. FDA also established a docket...

Bayer Prevails Over Dr. Reddy's at Trial in Avelox Case- Bayer AG v. Dr. Reddy's Laboratories, Ltd., No. 04-179 (D. Del. 2007) Last Thursday, the U.S. District Court for the District of Delaware held that two Bayer patents on Avelox (moxifloxacin hydrochloride) are valid and enforceable, and infringed by Dr....

EXACT Sciences: A Train Wreck or About to Leave the Station?-

In the spirit of election season, this article reflects my response and evidence to debate a Street.com article over the weekend on EXACT Sciences (EXAS) by School Specialty (Nasdaq: SCHS) Stock Report- A 2-page PDF stock research report for School Specialty (Nasdaq: SCHS) - a possible short sale candidate for aggressive traders.
October 31, 2007

3 Micro-Cap Biotech Stocks to SELL-
1.) Genitope (Nasdaq: GTOP): Clinical trial results for MyVax likely to disappoint.

2.) Favrille (Nasdaq: FVRL): FavId trial likely to fail.

3.) Pharmacyclics (Nasdaq: PCYC): Xcytrin NDA filed under protest with likely rejection by FDA with PDUFA date of 12/31/07.

October 31, 2007

Positive Commentary for EXACT Sciences (EXAS) & PreGen-Plus-
Gauging Risk For Colorectal Cancer Helps To Determine Screening Test

MIKE Index - 10/26/07 Performance & Tracking-
MIKE Performance & Stats: 7/21/07 - 10/26/07

Crystallex Closes in on Cristinas Permit-
Friday October 26, 11:47 am ET

TORONTO, ONTARIO--(MARKET WIRE)--Oct 26, 2007 -- Crystallex International Corporation (Toronto:KRY.TO - News)(AMEX:KRY - Positive Developments at BioSante-
23-Oct-07: The Company announced receipt of notification from The NASDAQ Stock Market LLC® that the Company’s common stock is approved for listing on The NASDAQ Global Market. The Company’s board of directors approved the decision to switch the listing of BioSante’s common stock from The American Stock Exchange to The NASDAQ Stock Global Market LLC®. BioSante currently is going through all the required regulatory processes associated with the swit

FDA Requests Comments on Exclusivity for Generic Altace-
For the second time in as many weeks, FDA has asked interested parties to submit comments regarding 180-day generic drug exclusivity issues. On September 26, as FDA Law Blog reported, FDA requested comments on exclusivity for generic Precose (acarbose) tablets; last week, FDA asked for comments

MIKE Index - 10/24/07-

Emerging Micro-Cap Index (MIKE)

Emerging Diagnostic Stock Valuations-
Shares of EXACT Sciences (EXAS) are poised for a major break-out upon colorectal cancer (CRC) screening guidelines in November which will bring its $107 million market cap more in line (or above) peers APPY ($377 million) & SQNM ($425 million). I expect EXAS to end the year around the $15 - $20 level with guidelines inclusion, positive V2 clinical trial results demonstrating better sensitivity than previous 88%, and clarity on the Company's strategy for an FDA-approved version of its sDNA CRC screening test.

The Celution™ for Commercial Success at Cytori-
Cytori Therapeutics (CYTX) is a leading global innovator in the emerging field of regenerative medicine using adipose (fat) tissue as a source for adult stem cells capable of differentiating into a variety of cell types. Research has shown that fat tissue is a rich source for a variety of regenerative and adult stem cells, despite the widespread use of bone marrow and other sources by many stem cell companies. The Company is developing therapeutic applications for its Celution System to enable real-

My Top Small & Micro-Cap Biotech Stock Picks-
My Top 10 Emerging Biotech Stock Rankings

(based on closing prices 11-Oct & expected near-term catalysts)

1) EXACT Sciences (EXAS): On the verge of exponential increase in share price with likely inclusion in CRC screening guidelines in November, V2 technology trial results due before EOY07, and pending NCD app for Medicare reimbursement of PreGen-Plus

iiBIG "New Directions for Drug Delivery" Conference, Las Vegas, October 29-30- The International Institute for Business Information & Growth will hold a conference entitled "New Directions for Drug Delivery," October 29-30 in Las Vegas, Nevada. The conference is designed for pharmaceutical scientists and specialty pharma, biopharmaceutical, and nanotechnology licensing and business...

Federal Circuit Affirms Injunction Against Apotex in Depakote Case, But Finds Apotex Was Not in Contempt- Abbott Labs v. Torpharm and Apotex, No. 2007-1019 (Fed. Cir. 2007) In 1997, Apotex filed an ANDA for generic Depakote (divalproex sodium), Abbott's blockbuster treatment for bipolar disorder, migraine headaches, and epilepsy. Abbott responded by filing suit against Apotex for...

Paddock Labs Prevails Over Schwarz Pharma in Univasc Case at Federal Circuit- Schwarz Pharma v. Paddock Labs, No. 2007-1074 (Fed. Cir. 2007) In a decision released this morning, the Federal Circuit affirmed a 2006 district court decision granting summary judgment of noninfringement of U.S. Patent No. 4,743,450 in favor of Paddock Labs....

EXACT Sciences 19 Page PDF Stock Research Report-
EXACT Sciences (Nasdaq: EXAS) is a genomic diagnostics company with an imminent catalyst plus triple digit stock price & billion dollar market cap potential from just $3.39/share & $100 million market cap at my report date of 10/4/07.

Put Alfacell (ACEL) on Your "A" List of Speculative Biotechs- Onconase is currently being evaluated in an international Phase 3b registration trial in patients suffering from inoperable malignant mesothelioma, and it was granted an orphan drug designation by the FDA for this indication in January. The primary endpoint of the trial is overall survival.

A Micro-Cap Stealth Defense Play- -the Company's operations are divided between commercial & defense electronics --> focused on the development of 3-D semiconductors for signal/image processing apps such as miniature infrared cameras for weapon sights & IR goggles

-over $35 million in TTM sales with a market cap of just $28.5 million

-the Company has a history of trading surges from low points on news of new contract wins, which appears likely in the near-term

Trading Over $1/Share May Become a Fond Memory After Key Trials- Top line data is expected from two key clinical trials in the 4Q07 for MEMY --> both are Phase 2a clinical trials for Alzheimer's disease (AD) for drug candidates MEM-3454 and MEM-1003.

In March 2007, Memory announced disappointing efficacy results in a Phase 2a trial of MEM-1003 for the treatment of bipolar mania, although the drug was well-tolerated. Despite the setback, investors are eagerly anticipating results of lead drug candidate MEMY-1003 in AD, with plans to initiate a larger Phase 2b trial by the first half of 2008 if the drug is shown effective.

ACI "Maximizing Pharmaceutical Patent Life Cycles" Conference, New York, October 24-25- American Conference Institute will hold its eighth annual "Maximizing Pharmaceutical Patent Life Cycles" conference October 24-25 in New York. According to ACI, this is the "one and only event that has consistently allowed brand name and generic drug makers to...

Emerging Micro-Cap Index (MIKE)-
Javelin Pharma (AMEX: JAV) (quote & news, website)

On2 (AMEX: ONT) Combines High-Quality Video & Low Bandwith-
-tech partners: Adobe Flash Player 8 and 9, Skype 2.0, AOL IM, Tencent Q/Q, Vividas and Move Networks

-ON2 develops the codec that is used by these players to play back and/or encode video

-can be applied for encoding of user-generated content, two-way videoconferencing and Internet Webcasts to having full-length TV content playing back on the Internet

-ongoing trials with China Mobile for playing back video on mobile

-ON2 provides a codec that scales from as little as 20 Kbps up to high definition

September 27, 2007

Pharmaceuticals & Biotech

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