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International biopharmaceutical company Cephalon (Frazer, PA)
completed its acquisition of Mepha (Switzerland), a privately
held pharmaceutical company, for $615 million. Mepha specializes in dosage formulations
and markets both generic and branded-generic products. Mepha manufactures and markets more than 120 products in 50 countries and reported 2009 sales of $380 million.
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Biopharmaceutical company Crucell (Leiden, The Netherlands) signed
a binding letter of agreement with GlaxoSmithKline Biologicals (London) to collaborate on developing a second-generation, malaria vaccine candidate. Under the terms of the agreement, Crucell will contribute its recombinant malaria vaccine candidate,
Ad35-CS, based on Crucell's AdVac technology and PER.C6 manufacturing platform, and
GSK will contribute its late-stage malaria vaccine candidate RTS,S/AS. Financial details were not disclosed.
CureDM (Wilmington, DE), a privately held biopharmaceutical
company, signed an exclusive manufacturing and marketing agreement with sanofi-aventis (Paris) for its Pancreate, an islet neogenesis agent for the treatment of Type I and Type II diabetes. sanofi-aventis gains the rights to manufacture, develop, and market Pancreate (proisletide acetate). CureDM will receive an upfront cash payment and sales performance milestone payments totaling $335 million. CureDM is also eligible to
receive increasing royalties on worldwide product sales.
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Javelin Pharmaceuticals (Cambridge, MA), a company providing technologies for new drug development and improved formulations of existing drugs, received a binding offer from specialty pharmaceutical company Hospira (Lake Forest, IL)
to enter into a merger agreement, a loan and security agreement, and intellectual property security agreements. Under the terms of the agreement, Hospira will acquire all outstanding shares of Javelin at $2.20 per share and provide Javelin working capital from which
Javelin may borrow up to $4.5 million to fund its operating activities prior to closing a merger with Hospira. Javelin will also receive $8.3 million for repayment of the principal and accrued interest incurred under a similar financing arrangement with Myriad
Pharmaceuticals (Salt Lake City, UT). Javelin will also receive $4.4 million
for its payment of the termination fee and certain stipulated expenses that it may be required to
pay Myriad following termination of their merger agreement.
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Penwest Pharmaceuticals (Patterson, NY), a drug-development company,
signed a drug-development and marketing agreement with specialty generics company Alvogen (Parsippany, NJ). Penwest and Alvogen will select up to five compounds for generic development. Penwest's TIMERx technology may be used for each compound selected. Penwest will receive milestone and royalty payments based on the development of each compound. Alvogen will be responsible for manufacturing, clinical trials, and regulatory filings for each of the formulations,
as well as marketing.
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Rx-360, the international pharmaceutical supply-chain consortium, is
calling for papers on best practices in supply-chain security. Visit their website for
more information or email Rx-360@dbr.com.
Swagelok (Solon, OH) acquired the shares of RHPS B.V. (Nieuw-Vennep, The Netherlands),
a manufacturer of high-quality pressure regulator products used mostly in oil and gas, chemical/petrochemical, alternative fuels,
semiconductor, biopharmaceutical, and other demanding applications. Terms of the purchase were not disclosed.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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| Last week,
the US Food and Drug Administration issued Warning Letters to six US medical spas and one Brazilian company for issuing misleading statements online about a medical procedure. The procedure, lipodissolve, involves a series of injections (i.e.,
phosphatidylcholine, deoxycholate, and other ingredients) and was promoted
online as being safe and effective at removing pockets of fat from the body. “FDA is not aware of any credible scientific evidence that supports the effectiveness of any of these substances for fat elimination, and their safety when used alone or in
combination is unknown,” said the agency in a press release about the Warning Letters. In addition, the agency has received adverse-event reports from
patients using these drugs. The companies that received the Warning Letters were:
Monarch Medspa (King of Prussia, PA), Spa 35 (Boise, ID), Medical Cosmetic Enhancements (Chevy Chase, MD), Innovative Directions in Health (Edina, MN), PURE Med Spa (Boca Raton, FL), and All About You Med Spa (Madison, IN). The Brazilian company comprised two websites: zipmed.net
and mesoone.com. Read the full Warning Letters.
Last week, Pharmaceutical Technology noted that FDA had published two new guidances for industry based on the Step-4 version of the International Conference on
Harmonization’s (ICH) Q4B Annexes 7 and 9. The agency has now published Annex 10 of the same ICH guideline as a guidance for industry. Annex 10 addresses polyacrylamide gel electrophoresis. FDA guidance based on ICH guidelines
allow industry to use the US Pharmacopeia, European Pharmacopeia, and Japanese Pharmacopeia interchangeably
for the tests described, although FDA can disallow interchangeability at any point.
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Specialty generics company Alvogen (Parsippany, NJ) appointed Elin Gabriel as its COO, Kevin Bain as its CFO, and Svafa Gronfeldt as its chief organizational development officer.
Xcellerex (Marlborough, MA), which specializes in modular-biopharmaceutical manufacturing systems, appointed Guy Broadbent as its president and CEO. He succeeds Joseph Zakrzewski, who served as chairman, president, and CEO.
Metrics (Greenville, NC), a contract pharmaceutical development and manufacturing company, appointed W. David Varley as its director of manufacturing operations. |
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Equipment Purchasing
Our manufacturing facility is purchasing more equipment to produce:
Highly potent dosage forms
Multilayer tablets
Liquid injectable drugs
Inhaled therapies
Transdermal patches
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View the poll archive. |
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Multifunction blender accommodates various bins
