AstraZeneca's ($AZN) last-ditch effort to hold off generic Seroquel has failed. A U.S. judge denied the drugmaker's request for a preliminary injunction that would delay copycat rivals, saying the company didn't prove that it qualified.The company had aimed to keep the Seroquel market to itself until December. That's when exclusivity expires on safety data that, AstraZeneca argued, should be included in any generic drug label. The company sued the FDA over the labeling issue, after the agency denied its internal request.So, as the Seroquel patent expires today, generic versions will roll onto the market. Several billion in annual sales are up for grabs; Leerink Swann's Seamus Fernandez sees a dropoff of $3.9 billion in the first 9 months of generic competition. And as the Wall Street Journal points out, Seroquel's patent expiration is just the first of three biggies over the next 5 years."This is a company that is probably facing one of the worst patent cliffs in the industry," Morningstar analyst Damien Conover told the Delaware News Journal. "That, coupled with a pipeline that hasn't produced enough offsetting new products, has really put the company in a challenging spot."AstraZeneca says it's weighing its options in the FDA lawsuit. Meanwhile, it's cutting costs, pushing hard to boost sales of existing drugs, looking for strategic acquisitions and scrambling to develop new drugs, an effort that has hit some big snags recently. Despite CEO David Brennan's repeated assurances to the contrary, analysts are playing name-that-potential-AstraZeneca-buyout, tagging such companies as Shire and Amylin Pharmaceuticals as likely prospects. But spokesman Tony Jewell says AstraZeneca will succeed by sticking to the knitting it has already begun: "We knew this was coming, and we have a business strategy," Jewell told the News Journal.- read the News Journal piece
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Tuesday, 10 April 2012
Preliminary Injunction-Patent Expiration-Astrazeneca-Seroquel-Company
Monday, 9 April 2012
Medicaid Managed Care-Unitedhealthcare-Medicaid Program-Company
D.C. political benefactor extraordinaire Jeffrey Thompson might make a lot of money by running the District’s Medicaid program, but his company’s smaller competitor can’t seem turn the trick.UnitedHealthcare Community Plan, the smaller of D.C.’s two Medicaid managed care contractors, lost $15 million on $181 million in revenue in 2012, its fourth consecutive money-losing year, according to an annual report recently filed with District insurance regulators.The company, a subsidiary of... (Source: bizjournals.com Health Care:Pharmaceuticals headlines) read more..
Friday, 23 March 2012
International Commercial Partnership-Alexza Pharmaceuticals-Public Offering-Fda Approval
Even with a beefed up international commercial partnership, a public offering, restructuring and layoffs, Alexza Pharmaceuticals ($ALXA) has disclosed that its cash could run out by year-end. And so stakes increase even further over the FDA's pending evaluation of Adasuve, the company's inhaled, fast-acting, vaporized formulation of the antipsychotic drug loxapine.Mountain View, CA-based Alexza just can't catch a break. As of Dec. 31, the company said it had just $16.9 million in cash, equivalents and securities on hand. And after taking steps earlier this year to raise more than $20 million in a public offering, slash 38% of its workforce (29 jobs), and boost its international commercial partnership stake with Grupo Ferrer, the company reported that current cash burn rates will only carry it through the 2012 fourth quarter.Alexza is struggling to gain FDA approval for Adasuve, which improves on the long-used oral version of loxapine to treat adults for schizophrenia-related agitation or bipolar I disorder. The drug is housed in the company's Staccato inhalation device, which delivers a vapor directly to the lungs and subsequently reaches the bloodstream quickly.We learned in January that the FDA delayed its review deadline from Feb. 4 to May 4, in order to review how Alexza is addressing changes to safety and dosage guidelines recommended by an FDA panel of experts in December. Its decision, clearly, could make or break the company. So May 4 could be Doomsday or Christmas. An FDA-approved Adasuve would compete with injectable drugs made by companies including Bristol-Myers Squibb ($BMY) and Eli Lilly ($LLY).Alexza booked a $9.7 million net loss during the fiscal 2011 fourth quarter and $40.5 million net loss for the fiscal year that ended Dec. 31.- read the financials releaseRelated Articles:
Alexza's Adasuve slapped with delayed FDA review
Alexza layoffs looming read more..
Tuesday, 20 March 2012
Institutional Investors-Share Purchase Warrants-Equivalent Number-Warrant Exercise
SAN DIEGO, March 19, 2012 (GLOBE NEWSWIRE) -- TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) ("TearLab" or the "Company") announced today that 1,373,700 share purchase warrants issued in connection with the Company's June 2011 private placement financing have been exercised by certain institutional investors into an equivalent number of common shares of the Company for total gross proceeds of approximately $2,555,000. Approximately 2,472,454 share purchase warrants issued in connection with the June 2011 financing remain outstanding. (Source: Medical News (via PRIMEZONE)) read more..