Warner Chilcott (NasdaqNM: WCRX) opened at $22.45. So far today, the stock has hit a low of $22.30 and a high of $22.89. WCRX is now trading at $22.48, down $0.67 (-2.89%). Over th...(Click the story link or go to http://www.marketintelligencecenter.com for the full story)

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The Women’s Health Initiative ('WHI'), a study that demonstrated several lethal side-effects of hormone replacement therapy ('HRT'), has left many pharmaceutical companies scrambling to advance alternative therapies to meet the unique market demand created by the drop in hormone sales. Although several therapies have advanced to late-stage clinical studies, few represent a truly novel approach.

Pristiq, Wyeth’s (NYSE:WYE) new treatment for depression and potentially –post menopausal hot flashes, is merely a metabolite of the multi-billion dollar blockbuster, Effexor. Aprella, Wyeth’s investigational combination product for the treatment of menopausal symptoms, repackages two commonly used classes of drugs; estrogens and selective estrogen receptor modulators. Instead of improvements in side-effects or enhanced efficacy, the pharmaceutical industry has employed a model where minor chemical alterations coupled with a profound marketing engine compensates for declining sales from products with patent expiration. It’s very seldom to find a pharmaceutical company that is developing a truly novel approach to therapeutics.

{tiny;BNVI;3}Enter Bionovo (NASDAQ:BNVI), a small drug discovery and development company that has discovered a completely new approach to “women’s health”, using ancient ingredients: plants. Bionovo’s flagship, plant-based product is called Menerba, and is slated to begin enrolling patients in its pivotal Phase III study in the first half of 2010. Besides Menerba, Bionovo is also developing compounds to treat breast cancer, pancreatic cancer, and vaginal atrophy: all using a plant-based model.

So far, the model has paid off for Bionovo. In its Phase 1 and 2 clinical trial, Menerba has effectively treated vasomotor symptoms with only one side effect, loose stool, while the incumbent therapy, HRT, has 7 black box warnings.

After Bionovo’s December meeting with the FDA, investors’ focus will shift to Menerba’s upcoming phase 3 trials. The first phase 3 trial will have three treatment arms; one arm will be using a 10 gram dose which was the lowest efficacious dose found in the Phase II, as well as a 20 gram dose and a 50 gram dose. Bionovo believes that Menerba’s dose-response curve tops out between the 20 gram and the 50 gram dose.

Menerba does have several challenges to face. Typically, clinical trials treating hot flashes tend to have a high placebo response. In fact, in a recent hot flash trial, the placebo reduced the frequency of hot flashes by 62%. In Menerba’s Phase II trial, the 10 gram dose reduced hot flash frequency by 62%.

Furthermore, recent research has demonstrated a predominance of beta estrogen receptors on platelets and the research community seems divided over whether beta estrogen receptor modulation is thrombolytic or thrombotic. To date, not one genomic, animal or human study with Menerba has demonstrated an increased rate of thrombosis.

Nonetheless, Menerba has the potential to become a best in class product and Bionovo has assembled an extensive scientific advisory board to address all of the challenges that it may face. Their management has recruited top statisticians to review recent trial results, in order to optimize Menerba’s trial design and minimize confounding factors like a high placebo response.

Management has indicated that the second phase 3 study for Menerba will have a 12 month safety endpoint which should be sufficient for FDA approval. Bionovo’s management has also indicated that the second phase 3 trial will be completed by a soon-to-be announced partner. In a recent conference call, Bionovo’s chief executive officer hinted that a partnership may come before trial enrollment, although it’s not clear if he was speaking generally or specifically about Bionovo. I guess we won’t find out until “late in the first quarter” which is when Bionovo’s chief medical officer hopes to begin Menerba’s phase 3 trial.

Potential partners for Menerba, include Teva Women’s Health (NASDAQ: TEVA) which is the manifestation of Teva’s purchase of Barr and Duramed, and Warner-Chilcott (NASDAQ:WCRX) who has a long track record in the women’s health space, as well as some other mid-size pharmaceutical companies.

The treatment of menopausal symptoms is a multi-billion dollar market, and I expect Bionovo to be quickly revalued to the upside, when they initiate their trial for Menerba, and announce a sizable partner. With a market capital of less than $50 million and a recent stock price of 50 cents, I believe Bionovo’s share price is poised to move higher.

Disclosure: Long BNVITro Kalayjian is a medical student, contract consultant, and contributing writer at Seeking Alpha, BioMedReports and ThreeBrothersHealth.comHe consults on a contractual basis and provides initial due diligence and quarterly updates on Biotechnology, Pharmaceuticals, Drug delivery and Drug discovery

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Below is a list of the companies that made news in the healthcare sector on Friday, October 30, 2009. Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

Biodel Inc. (Nasdaq:BIOD) announced Dr. Solomon Steiner, Chairman and CEO of Biodel, will present a corporate update at the Oppenheimer 20th Annual Healthcare Conference on November 3rd, 2009 at 9:40 am Atlantic Time.

AMRI (NASDAQ:AMRI) announced AMRI Director of Investor Relations Peter Jerome will present at the Oppenheimer 20th Annual Healthcare Conference in New York City on Tuesday, November 3, 2009 at 3:20 p.m. EST.

BioScrip, Inc. (Nasdaq:BIOS) announced third quarter net income of $5.7 million, or $0.14 per diluted share, on revenues of $333.5 million. These results compare to net income of $1.4 million, or $0.04 per share, on revenues of $359.4 million for the third quarter of 2008.

Celgene Corporation (NASDAQ:CELG) announced its presentation at the Oppenheimer & Co. Inc. 20th Annual Healthcare Conference on Wednesday, November 4, 2009 at 10:15 a.m. ET will be webcast live and will be available in the investor relations section of the company’s Web site at www.celgene.com. Celgene management will provide an overview of the company.

ARYx Therapeutics, Inc. (NASDAQ:ARYX) announced it will present at the Oppenheimer 20th Annual Healthcare Conference in New York on November 4, 2009 at 10:15 am Eastern.

Javelin Pharmaceuticals, Inc. (NYSE:JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, received commitments from a single institutional investor, to purchase up to 3,186,700 shares of its common stock for estimated gross proceeds of approximately $3.9 million.

China-Biotics, Inc. (Nasdaq:CHBT), a leading Chinese firm specializing in the manufacture, research, development, marketing and distribution of probiotics products, announced the appointment of Dr. Tom Gu as Vice President, effective November 2.

BMP Sunstone Corporation (Nasdaq:BJGP), announced it will participate in the following conferences: -- Oppenheimer 20th Annual Healthcare Conference, to be held November 3-4, 2009 at the Waldorf=Astoria hotel in New York.

Warner Chilcott plc (Nasdaq:WCRX) announced it has completed the acquisition of The Procter & Gamble Company's global branded prescription pharmaceutical business.

NeoStem, Inc. (NYSE:NBS), announced the Company has completed theacquisition of China Biopharmaceuticals Holdings, Inc. (OTC Bulletin Board: CHBP), a leading Chinese pharmaceutical company.

Javelin Pharmaceuticals, Inc. (NYSE:JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, received commitments from a single institutional investor, to purchase up to 3,186,700 shares of its common stock for estimated gross proceeds of approximately $3.9 million.

BSD Medical Corporation (NASDAQ:BSDM) announced published study results demonstrated improvement in overall survival, tumor response rates, and local tumor control from the addition of hyperthermia therapy, delivered using the BSD-2000 Hyperthermia System, to the standard treatment regimen for 45 patients with high-risk bladder cancer.

Safeguard Scientifics, Inc. (NYSE:SFE), a holding company builds value in growth-stage life sciences and technology companies, announced it will release its financial results for the third quarter ended September 30, 2009 prior to market open on Wednesday, November 4, 2009.

Emergent Health Corp. (OTC:EMGE) Emergent (the “Company”) is pleased to announce a forward stock split of 11 shares for each 10 shares owned.

NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced it will hold a conference call on Friday, November 6, 2009 at 9:00 a.m. ET (6:00 a.m. PT) to report results for its third quarter 2009.

Rosetta Genomics (NASDAQ:ROSG) announced Ayelet Chajut, its Executive Vice President, R&D, Head of Molecular Biology will speak at the 6th International Conference on Circulating Nucleic Acids in Plasma and Serum (CNAPS-VI).

Shire plc (NASDAQ:SHPGY) the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.

Valeant Pharmaceuticals International (NYSE:VRX) announced it has agreed to acquire the rights to several prescription and cosmetic dermatology products from a privately-held, Polish specialty pharmaceutical company.

Impax Laboratories, Inc. (NASDAQ:IPXL) confirms it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICO® (fenofibrate) tablets, 48 mg and 145 mg.

PharMerica Corporation (NYSE:PMC), a national provider of institutional pharmacy and hospital pharmacy management services, announced Michael J. Culota, Executive Vice President and Chief Financial Officer, will make a presentation regarding the Company at the Oppenheimer 20th Annual Healthcare Conference in New York City on Tuesday, November 3, 2009, at 10:50 a.m. Eastern Time.

Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, announced it will report financial results for the third quarter ending September 30, 2009 on Wednesday, November 4, 2009, after the U.S. financial markets close.

Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK) announced it is scheduled to make an investor presentation at the 20th Annual Oppenheimer Healthcare Conference. David Seltzer, President and Chief Executive Officer, will deliver the Company's presentation on Tuesday, November 3, 2009, at 3:55 p.m. Eastern Time.

GTx, Inc. (NASDAQ:GTXI) announced it will host a conference call and webcast on Monday, November 2, 2009 to provide an update regarding the New Drug Application for toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy.

Talecris Biotherapeutics Holdings Corp. (Nasdaq:TLCR) will release its third quarter 2009 financial results on November 9, 2009, after the stock market closes, and will host a conference call at 8:30 AM Eastern Time on November 10, 2009.

Covidien (NYSE:COV), a leading global provider of healthcare products, announced its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII).

Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, announced it will report financial results for the third quarter ending September 30, 2009 on Wednesday, November 4, 2009, after the U.S. financial markets close.

Novavax, Inc. (Nasdaq:NVAX) announced it will report its 2009 third quarter financial results in a press release to be issued after 8:00 am local time on Friday, November 6, 2009.

Geron Corporation (Nasdaq:GERN) announced the company’s plan to advance clinical development of its human embryonic stem cell (hESC)-based produc , GRNOPC1, for the treatment of spinal cord injury.

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Motorola Inc. (MOT) today declared financial results for the third quarter 2009. Quarterly net income from continuing operations was $12 million or 1 cent per share, compared to a net loss of $397 million or 18 cents per share in the prior quarter. Third quarter adjusted (excluding special items) EPS was 2 cents, easily beating the Zacks Consensus Estimate of a break-even quarter.[More...]