Teva Pharmaceutical (NasdaqNM: TEVA) closed yesterday at $53.04. So far the stock has hit a 52-week low of $39.75 and 52-week high of $54.95. Teva Pharmaceutical stock has been showing support around 52.23 and resistance in the 53.53 range. Technical indicators for the stock are Bullish and S&P gives TEVA a very posit...(Click the story link or go to http://www.marketintelligencecenter.com for the full story)
Teva Pharmaceutical (NasdaqNM: TEVA) closed yesterday at $53.06. So far the stock has hit a 52-week low of $39.75 and 52-week high of $54.95. Teva Pharmaceutical stock has been showing support around 52.05 and resistance in the 53.63 range. Technical indicators for the stock are Bullish and S&P gives TEVA a very positi...(Click the story link or go to http://www.marketintelligencecenter.com for the full story)
Israeli stocks trade little changed, with gains in a couple of the telecoms and scattered interest in technology stocks offset by weakness in Africa-Israel, Teva Pharmaceutical and Israel Chemicals.
Sinobiopharma, Inc. (SNBP), a specialty drug producer similar to Teva Pharmaceuticals (TEVA) and Par Pharmaceuticals (PRX), announced that 23 of its generic drugs are listed in China’s National Essential Drugs List and will be covered by the basic insurance plan supported by the government in its universal healthcare reform slated for 2010.
Sinobiopharma, Inc. (”Sinobiopharma” or, [...]
Glumetza is a long-acting, timed release, once daily version of the drug that now finally can take full advantage of the effects of Metformin to normalize blood sugar in patients with type II diabetes while minimizing the side-effects associated with Metformin. The drug works by reducing the amount of sugar produced in the liver, and the amount of sugar absorbed in the body. It also helps the body respond better to its own insulin, thereby reducing instances of damaging high levels of blood sugar. Think of Glumetza as a once-a-day wonder drug for the approximately 19 million people in the US suffering from adult-onset, or type II diabetes.
Since the FDA approved the drug early last year, it has slowly started to penetrate the marketplace. The small company behind the drug is Depomed (NASDAQ: DEPO) of Menlo Park, CA. Late summer last year, Depomed inked a deal with a larger company, Santarus (NASDAQ: SNTS) of San Diego, CA, to market and sell the drug in the US using its well established sales and marketing network.
In the deal, Santarus paid Depomed an up-front payment, while Santarus in turn will receive 75-80% of the gross margin from sales of Glumetza. Both companies were winners in this deal, as Depomed received much needed cash in the credit crunch and cash strong Santarus will have huge earnings potential as sales of Glumetza takes off. The market potential for Glumetza is so large that pharmaceutical companies are lining up to get a piece of the pie. Their technology has already been challenged by Bristol Myer Squibb (NYSE: BMY) and Ivax, a subsidiary of Teva Pharmaceuticals (NASDAQ: TEVA), and in recent news, Lupin Pharmaceuticals is again attempting to invalidate their patents.
I see little cause for concern as Depomed has already reached other agreements with both Ivax and Bristol Myer Squibb, and this market is big enough for multiple players. In the longer run, it is Santarus who stands to make the most from Glumetza of course. Santarus started marketing the drug in the fourth quarter of 2008, and after a year can now show a very promising growth in the sales of Glumetza with prescriptions currently at around 79,000 patients at the end of the third quarter, turning in a 20% growth over the second quarter of this year.
Most patients on the drug will be on it permanently, and since there are 19 million type II diabetes sufferers in the US, the room to grow here makes Glumetza a potential billion dollar blockbuster drug, and sales should continue to see exponential growth as the word gets out to physicians and patients across the country. Although the growth in sales is currently at a rate of doubling every year, it can become even more explosive at any moment as reimbursement for the drug is expected to become widespread. It is not a very expensive drug in the first place at about $4 per day, making the price about $1500 per patient per year depending on the dose, which is customized for each patient with help from their physician.
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.Akorn, Inc. (NASDAQ:AKRX) a specialty pharmaceutical company, reported financial results for the third quarter ended September 30, 2009.Allos Therapeutics, Inc. (NASDAQ:ALTH), a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics announced management will present at two upcoming conferences: the Lazard Capital Markets 6th Annual Healthcare Conference and the Windhover Therapeutic Area Partnerships event, where the Company’s Pralatrexate for Peripheral T-cell Lymphoma project was named as one of Windhover’s Top 10 interesting oncology projects.ArQule, Inc. (Nasdaq:ARQL) announced it will present at the Lazard Capital Markets 6th Annual Healthcare Conference on Tuesday, November 17, 2009 at 5:10 p.m. eastern time.Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced researchers are scheduled to present data relating to Soliris® (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) during the 51st Annual Meeting of the American Society of Hematology (ASH), to be held December 5 – 8, 2009 at the Ernst N. Morial Convention Center in New Orleans.Biogen Idec Inc. (NASDAQ:BIIB) announced its presentation at the Lazard Capital Markets 6th Annual Healthcare Conference will be webcast live, via the internet, on Tuesday, November 17, 2009 at 10:55a.m. EST.Elan Corporation, plc (NYSE:ELN) announced it will present at the Lazard Capital Markets 6th Annual Healthcare Conference, on Tuesday, November 17, 2009 at; 9:55 a.m. Eastern Time and 2:55 p.m. GMT.Genoptix, Inc. (Nasdaq:GXDX), a specialized laboratory services provider, announced the Company's participation at the Lazard Capital ManaGement 6th Annual Healthcare Conference at The St. Regis Hotel in New York City on November 17-18, 2009.Impax Laboratories, Inc. (NASDAQ:IPXL) announced the Company will present at the Credit Suisse 18th Annual Healthcare Conference on Friday, November 13th, at 10:00 a.m. Mountain Standard time.ImmunoGen, Inc. (Nasdaq:IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, announced several ImmunoGen poster presentations will be made at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics to be held in Boston, MA, on November 15-19, 2009.The positive mix lift expected as farmers choose to upgrade to next-generation technologies allows Monsanto Company (NYSE:MON) to reconfirm its commitment to double its 2007 gross profit in 2012, Monsanto President and CEO Hugh Grant will tell investors.Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, announced Gerald T. Proehl, president and chief executive officer, will make a presentation at the Lazard Capital Markets 6th Annual Healthcare Conference on Tuesday, November 17, 2009, at 10:55 a.m. Eastern time (7:55 a.m. Pacific time) at the St. Regis Hotel in New York City.S3 Investment Company, Inc. (OTC:SIVC) announced the company's wholly owned Redwood Capital subsidiary has received payment valued at over $500,000 in the form of cash and stock from the recent closing of a client equity offering.Sigma-Aldrich® (Nasdaq:SIAL) announced it has entered into an exclusive worldwide distribution agreement with Stemgent, Inc. to offer Stemgent's portfolio of lentivirus-based delivery systems for the generation of induced pluripotent stem (iPS) cells.Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Takeda Pharmaceuticals North America, Inc.'s Prevacid® (Lansoprazole) SoluTab.Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Tap Pharmaceutical's proton pump inhibitor Prevacid® (lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg. Customers will begin receiving product on November 11, 2009.Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) announced holders of its 4.75% Convertible Senior Subordinated Notes due 2013 have agreed to exchange approximately $109.0 million in aggregate principal amount of those notes and accrued interest for approximately 4.8 million shares of the Company’s common stock, which is approximately 140,000 shares more than the number of shares into which the notes were convertible under their original terms.
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
While I've traded Dr. Reddy's Laboratories (RDY) in the past, I have not touched it in the past few years; however as we await for the new Market Vectors Indian Small Cap fund to launch I was poking my nose around Indian stocks this weekend since the Indian market has corrected quite a bit (and rebounded from oversold levels last week). So this name came back onto my radar in the limited universe of Indian ADRs. (full list of Indian stocks available at TickerSpy)[More...]
Companies featured in this segment: Westlake Chemical Corporation’s (NYSE:WLK), Teva Pharmaceutical Industries Limited (NASDAQ:TEVA), Novartis AG (NYSE:NVS), Watson Pharmaceuticals (NYSE:WPI), GDF Suez SA (EPA:GSZ), Iberdrola SA (MCE:IBE), Scottish and Southern Energy (LON:SSE), Siemens AG (NYSE:SI), Areva SA (EPA:CEI), Electricite de France SA (EPA:EDF), National Fuel Gas Company (NYSE:NFG), The Hinduja Group, International Power plc (OTC:IPRPY), NTPC Limited (BSE:532555), Ashok Leyland Limited (BSE:500477), Gulf Oil Corporation Limited (BSE:506480), Hinduja Foundries Limited (BSE:505982), IndusInd Bank Limited (BSE:INDUSINDBK), HTMT Global Solutions Limited (BSE:532859), RWE AG (OTC:RWEOY), E.ON AG (OTC:EONGY), Weyerhaeuser Company (NYSE:WY), VeraSun Energy Corporation (NYSE:VSE), and Valero Energy Corporation (NYSE:VLO).
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