Posted on December 13, 2007 @ 06:26 am
The board of directors at Biogen Idec have elected to keep the company independent, after a two-month flirtation with selling out to a larger company. The company announced that it did not receive "any definitive offers" for an acquisition. Company shares dropped 28% in value after the announcement
Refocused on its independent status, the company reiterated its year-end 2010 goals:
- Get 100,000 patients on Tysabri;
- Derive more than 40% of the its revenue from international business;
- Launch four new products and/or existing products in new indications;
- Have six programs in late-stage clinical development; and
- Generate revenue growth at a 15% compound annual growth rate (CAGR) and non-GAAP EPS at a 20% CAGR from 2007 through 2010.
Elan, BI's collaborator in Tysabri, announced that it will continue to work with BI on gaining FDA approval of Tysabri for Crohn's disease and building the drug's presence among multiple sclerosis patients.
Posted on December 13, 2007 @ 06:19 am
Merck has initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, PEDVAXHIB, and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, COMVAX . The recall is specific to these 13 lots and does not affect any other vaccines manufactured by Merck. The affected doses of PEDVAXHIB and COMVAX were distributed starting in April 2007.
The company is conducting this recall because it can not assure sterility of these specific vaccine lots. Routine evaluation of manufacturing processes revealed the potential contamination of the lots in question. Sterility tests of the vaccine lots that are the subject of this recall have thus far not found any contamination in the vaccine.
"The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low," according to a company statement. Still, the company contends that the risk is large enough to warrant a recall.
Merck is working closely with the FDA and CDC to inform affected healthcare providers of this recall. The company is also in the process of communicating with public health authorities and healthcare providers in the U.S. and in other countries where these lots were distributed, as appropriate.
"We are taking this action because we are committed to ensuring the quality of our vaccines," said Mark Feinberg, M.D., Ph.D., vice president, Medical and Policy Affairs, Merck Vaccines and Infectious Diseases. "We know that our vaccines can play an important role in the nation's public health system, and we are committed to resolving this issue as quickly as possible to ensure that our vaccines are readily available."
Physicians are advised not to administer any vaccine from the vaccine lots being recalled. Individuals who received vaccine from these lots should complete their immunization series with a Haemophilus b conjugate-containing vaccine not affected by this recall, but do not need to be revaccinated to replace a dose they received from a recalled lot. The efficacy of the vaccine was not affected.
Posted on December 13, 2007 @ 06:14 am
Novartis has announced a restructuring plan called, "Forward," to reduce costs and improve efficiencies. According to a company statement, the plan "is expected to simplify working processes and decision making by eliminating layers, concentrating on core activities and systematically capturing growth opportunities, particularly in emerging markets." This will include firing 2,500 staffers -- out of a total of 100,000 -- as part of its strategy to generate $1.6 billion in annual savings. Novartis will take a $450 million charge in 4Q07 to pay for the restructuring.
The company cited the standard set of "industry challenges" to explain the need for a restructuring: price pressures on drugs, growing R&D costs, a risk-averse regulatory environment and more aggressive generic competitors, the latter of which Novartis benefits from, thanks to its generics division, Sandoz.
"Forward" will include the following initiatives, as quoted from Novartis' press statement:
- Organizational structures will be streamlined in corporate functions as well as in the Pharmaceuticals and Consumer Health Divisions, particularly involving general management and administrative areas.
- In the Pharmaceuticals Division, the effectiveness of the worldwide sales forces will be improved with a more geographic-tailored marketing approach. Duplication between global, regional and local activities will be eliminated, while certain non-core support activities will be outsourced.
- The Consumer Health Division will remove organizational layers to streamline processes and eliminate duplications, while some product supply chains will be restructured to optimize capacity utilization. In certain business units, regional management structures will be modified in order to better focus resources on global or local activities.
- The Novartis Institutes for BioMedical Research will focus on disease areas with significant new opportunities and review its research activities globally to take advantage of synergies among disease areas and locations to increase efficiency.
- Initiatives are underway to capture savings from the creation of Group-wide shared functions, including procurement and information technology, that will provide greater economies of scale and leverage opportunities in low-cost countries.
- Novartis will form a new cross-divisional operation to accelerate growth in small emerging markets, expanding the presence of all Novartis products in regions that include Northern and Sub-Saharan Africa, Central Asia and parts of Southeast Asia.
The company announced that firings "will be handled in a socially responsible manner with fair and respectful treatment of associates," and that it will with works councils and comply with local labor laws.
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