Archives for December 2008
Minrad and Piramal to Merge
Piramal Healthcare Limited will acquire Minrad International for $.12 per share plus the assumption of debt. The total transaction, valued at approximately $40 million, is expected to close in the first quarter of 2009.
Piramal, an Indian pharmaceutical giant with a market capitalization north of $45 billion, is aggressively building its Critical Care business globally. The strategic combination will give Piramal access to key intellectual property for the manufacture of inhalation anesthetics, including process-based intellectual property for both sevoflurane and desflurane, and will provide Piramal an immediate entry into the U.S. market for sevoflurane, the largest selling inhalation anesthetic in the U.S.
Upon completion of the merger, the combined company will have a marketing and sales presence in 108 countries with 178 distributors, capable of supplying anesthetic products to supply chain vendors and end users. Piramal expects the transaction to be accretive to its
NovaDel: Longs May Finally Get a Good Night’s Sleep
The FDA has approved NovaDel’s Zolpimist, an oral spray for the short-term treatment of insomnia. Zolpimist contains zolpidem tartrate, the same active ingredient found in Ambien. Until recently, the U.S. patent for zolpidem was held by the French pharmaceutical giant Sanofi-Aventis. In April 2007, the FDA approved 13 generic versions of the drug.
Using NovaDel’s oral spray, zolpidem is absorbed through the oral mucosa directly into systemic circulation. In bypassing the GI tract and liver, the same therapeutic benefits can be achieved more quickly. The drug can reach effective blood levels in as little as 10-15 minutes.
The FDA accepted NovaDel’s New Drug Application (NDA) for Zolpimist in January. In keeping with the company’s regulatory strategy, the NDA was submitted using the 505(b) (2) path. This allowed NovaDel to rely upon the FDA’s findings of safety and efficacy for a previously approved drug,
[Incubator Profile] UAMS BioVentures
OneMedPlace would like to welcome UAMS BioVentures as a founding member of our Portfolio Development Group. BioVentures, will discuss its innovative business practices at the upcoming OneMedForum in January. The presentation will include a snap shot of the incubator facility and a brief overview of its top client companies.
UAMS BioVentures is a business incubator at the University of Arkansas for Medical Sciences (UAMS). The University established BioVentures in 1997 to facilitate technology transfer and the development of startup companies based on University technology.
In the past decade, UAMS-generated products have created 316 jobs with an annual payroll of $15.7 million. BioVentures now has 12 projects under management. In addition to a host of support services, the program organizes regular life science and biomedical engineering private equity roundtables that connect its risk capital members with new technologies and client companies.
Client companies include:
[Company Profile] OptiNose
OptiNose’s breath-actuated devices deliver intranasal drugs to targeted regions of the nasal cavity, including the sinuses and the olfactory region, without lung deposition, a major problem for traditional nasal inhalers, nasal sprays or nebulizers.
OptiNose technology has significant market potential in several major disease areas. The company’s devices can deliver drug to the upper posterior segment of the nose where it can access the entrances to the sinuses to treat rhinitis and sinusitis. These conditions are inadequately resolved by current therapies because drug does not reach the intended site.
OptiNose technology can also target the olfactory region from which drugs are able to readily pass directly into the brain. This “nose to brain” delivery offers exciting opportunities for treating disorders of the central nervous system, such as Parkinson’s and Alzheimer’s.
Additional applications are envisaged in the treatment of pain, migraine, and sexual dysfunction. The
AngioDynamics’ NanoKnife: “Unique and Remarkable” Absence of Post-Operative Pain
AngioDynamics announced the use of its Irreversible Electroporation (IRE) technology on a lymph node metastasis and the first lung lesion case.
The procedures were judged successful from a safety perspective. The hospital will conduct further patient follow-up before determining tumor response. These are the fifth and sixth cases using NanoKnife at The Alfred.
Commenting on the patient response, Dr. Ken Thompson, leader of the Study, said, “We have also treated tumors in the liver and kidney with NanoKnife, with similar experiences – no postoperative pain at all – and the procedures have raised no safety concerns.”
Thomson has been an interventional radiologist since 1974 and describes the absence of post-operative pain as “unique and remarkable”.
Unlike thermal ablation modalities like cryo-ablation, microwave, and radiofrequency ablation, IRE damages the cell membrane causing cell death but sparing surrounding structures like blood vessels and nerves. By lessening collateral damage,
CompuMed Secures $4 Million for Strategic Initiatives
CompuMed has secured a $4 million line of credit, allowing the telemedicine company to pursue strategic initiatives even in this challenging financing environment. The funds will provide immediate working capital for growth and potential acquisitions.
The new credit facility supersedes a previous agreement with Boston Avenue Capital and carries more favorable terms. The revolving line of credit matures on December 31, 2010, and provides the company with the right to draw down up to $ 4 million by unanimous board action. The company has no obligation to access the facility.
CompuMed is best known for The CardioGram, one of the first telecommunication networks designed to remotely interpret electrocardiograms. CompuMed also offers OsteoGram, a noninvasive diagnostic system used in osteoporosis screening. In 2007, the company had revenues of $2.2 million on a $1.3 million loss.
Previously: Arizona Prisoners Can Take Heart
Citing a Lack of Funds, PLC Systems Defers RenalGuard Trial
It’s been over 18 months since PLC Systems enrolled the first patients in its RenalGuard clinical trial. It now appears the company’s efforts may have been for naught. PLC has deferred the trial pending further funding.
RenalGuard received CE Mark approval in late 2007; commercialization efforts in Europe are ongoing. The therapy is targeted to patients with diminished renal function who may be at risk for Contrast-Induced Nephropathy (CIN), most commonly defined as renal failure occurring within 48 hours of exposure to radiographic contrast media.
RenalGuard is a real-time fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. Based on existing data, PLC believes initiating and maintaining high urine output will allow the body to rapidly eliminate contrast media, reducing its toxic effects.
Approximately seven million patients worldwide undergo interventional therapeutic and diagnostic procedures each year. CIN
Synthes Prevails Against Medtronic
Synthes, a maker of spine and bone implants, has prevailed in a court battle with device-giant Medtronic. Synthes alleged that Medtronic had willfully infringed on patents covering its artificial disc line, ProDisc-L, by launching a competitive line of discs named Maverick. The Memphis, TN-based jury agreed.
Sythes is entitled to lost profits for half of the infringing sales, plus a royalty of 18% on the remaining sales. That sum was calculated at $7.4 million, though total damages will be determined by post-trial.
Medtronic can continue selling the discs but must pay Synthes royalties on any sales. The Maverick line is currently sold internationally; the company is (was?) pursuing FDA clearance to sell them in the U.S.
“We are pleased with the jury’s verdict,” said Michel Orsinger, President and CEO of Synthes. “These findings reflect the strength of Synthes’ spine patent portfolio.”
Synthes acquired the
Synergetics USA: Shift in Corporate Strategy Yields Strong First Quarter Results
Synergetics USA reported first quarter revenues of $12.2 million, an increase of 17% over the year ago period. More compelling was the increase in net income: $661,000 in the most recent quarter compared to $397,000 in Q1 2008, a 66% improvement.
In the past year, the Synergetics team, led by Chairman Robert Dick, has implemented various programs that have helped grow top-line revenue, reduce debt, increase profitability and improve operational efficiencies.
Products introductions (over the past two years) now account for 21% of total sales. In November 2007, Synergetics launched a lower priced electrosurgical generator, Malis. The effort was needed after competing manufacturers flattened the formerly healthy margins of its premium product line. The new unit fills the price gap created by its coagulation only unit, COAG, and the up-market Advantage, named DualWave.
“This unit will provide us with selling options, especially when confronted
Patient Enrollment for Monovisc U.S. Clinical Trial Complete
Anika Therapeutics, a developer of products for tissue protection, healing and repair, has completed patient enrollment for its Monovisc U.S. clinical trial. The randomized, double-blind study is designed to demonstrate that the single-injection viscosupplement therapy safely provides knee pain relief in patients with osteoarthritis.
Monovisc got CE Mark approval last year and is now available in the EU for the treatment of osteoarthritis symptoms in all synovial joints. Commenting on that approval, Charles Sherwood, President and CEO of Anika, said,
“Monovisc is being very well received in Europe, where we launched the product in May. Coincident with that launch, we completed a post-approval study of Monovisc in Europe and the interim results on the product’s performance and duration of action are very strong.”
Clinical data appears to replicate the safety and efficacy of Anika’s popular Orthovisc (a similar treatment for pain resulting from osteoarthritis
