Spotlight on Pharmaceuticals and Healthcare – latest developments

21 Jun

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Strategic acquisition of Parts

GE Healthcare’s Korean division has formed a global supply deal with local x-ray imaging provider Rayence, a subsidiary of Vatech Co, for its line of CMOS detectors. It will also acquire certain of Rayence’s Mammography assets. The Mammography assets of Rayence will become part of the Detection & Guidance Solutions (DGS) business unit of GE Healthcare.

General Manager  of Women’s Health, GE Healthcare, Detection & Guidance Solutions (DGS) Prahlad Singh declared, “At GE Healthcare we are very excited about the future of Women’s Healthcare. With the mammography assets of Rayence, tailored for regions with specific cost and access needs, we add capability that allows us to bring affordable mammography solutions to new users and rural communities around the world, in particular physicians undertaking screening programs for breast cancer diagnosis…when combined with GE’s core imaging capabilities, we will create a system that will have best in class image quality at the lowest total cost of ownership.”

Rayence’s core products includes a full range of Flat Panel Detectors (FPD) based on a-SI (amorphous silicon) technology, but the biggest feather in its cap is the CMOS line. Based on Active Pixel Sensor Technology, they combine lower power demands with high spatial resolutions from 20 um to 200 um pixel and, crucially, a lower radiation dose.

James Hyun, CEO of Rayence said, “This deal is meaningful in that Rayence has secured a solid global business partner for supplying CMOS detectors. I am very pleased that Rayence’s technology capabilities were acknowledged and products made by Rayence will be distributed to the world by GE Healthcare, thereby contributing to the enhancement of women’s health. Rayence plans to invest the money earned through the sale of our mammography assets into the R&D of core parts for x-ray devices including detectors and expansion of manufacturing lines.”

 

Pharma Giants form R&D Consortium

Three pharmaceutical conglomerates with a heavy presence in Asia became joint founders of an R&D programme managed by the Institute of Chemical and Engineering Sciences (ICES), itself a member of the Agency for Science, Technology and Research (A*STAR). Pfizer Asia Pacific, Glaxo Wellcome Manufacturing and Siemens will collaborate to address regulatory challenges and the costs of bringing drugs to market.

In addition, use of facilities such as the ICES’ Kilo Scale Laboratory will enable them to road-test products already processed on a small-scale on a mass production level. Containment and explosion-proof facilities allow, respectively, for processing of toxic and highly flammable materials. A pilot scale multipurpose continuous plant takes a product through the production stage.

Prior laboratory testing (calorimetry) and process studies such as HAZOP are undergone in a separate fully equipped laboratory, with staff experienced in process development and operation . Process analytics (PAT) and Quality by Design (Qbd) enhance their responsiveness to specific patient demands, and clinical trials.

Executive Director of ICES Dr. Keith Carpenter said, “ICES has built strong and deep capabilities in the understanding of process science and technologies and the time is ripe for such depth and breadth of knowledge to be applied to the chemicals and pharmaceutical industries. By identifying common research focus, companies can mutually benefit from joint research. This will enable companies to address industry-wide challenges and further reinforce the competitiveness of Singapore’s chemicals industry.”

Mr. Lim Hock Heng, Managing Director of GlaxoSmithKline’s Pharmaceutical Manufacturing Sites Singapore, stressed the mutual advantages to firms participating in the scheme: “At a time when companies in the pharmaceutical industry are challenged on speed in new product development, manufacturing process innovation, consistency in product quality, regulatory conformance and environmental sustainability, an integrative approach to the application of cutting edge technologies will be crucial to future success. The launch of iPSP is very timely.”

BioSante uses Royalties on Female Testosterone Gel to fund merger with Subsidiary ANI

BioSante Pharmaceuticals completed the merger announced in its plan of April 12, 2013, with the contract manufacturing company ANI, launched in 2008. ANI executed contracts for specialist and also toxic drugs such as those to fight cancer, for both BioSante and external contractors.

New CEO Arthur S. Przybyl stated “This merger is the catalyst for potential future growth. We now have a strong balance sheet with over $10 million in cash and no debt. We expect to utilize the incremental cash available to us as a result of this merger in two ways: to accelerate our product development efforts and for potential accretive acquisitions.”

As part of the move, BioSante issued to the holders of ANI series D convertible preferred stock an aggregate of 32,814,504 shares of BioSante common stock, representing around 57 percent of the outstanding shares of BioSante common stock immediately after the merger. Consequently, BioSante now operates under the leadership of ANI’s management team.

In addition to Mr. Przybyl, the new board of directors of BioSante consists of Robert E. Brown Jr., Tracy L. Marshbanks, Ph.D. Thomas A. Penn and Robert Schrepfer (all formerly of ANI), as well as Fred Holubow and Ross Mangano (both formerly of BioSante).

Pryzbyl laid out the new company’s market position: “We currently manufacture and market seven prescription products that we either developed internally or acquired. ANDAs for five additional generic products are pending at the FDA and we expect to submit six additional ANDAs in the remainder of 2013. These eleven generic products address a total annual market size of approximately $760 million, based on data from IMS Health.”

Immediately prior to completion of the merger, the BioSante board of directors authorized, declared and enacted a distribution of contingent value rights (CVRs) to holders of record of BioSante common stock outstanding immediately prior to the merger’s completion, with one CVR allocated per one share of common stock.

The CVRs represent payment rights arising from a future sale, transfer, license or similar transaction(s) involving BioSante’s LibiGel (female testosterone gel), includinImageg a royalty on sales of LibiGel if the combined company launches the product on its own and, and provided less than $2.5 million is spent on further product development before launch.

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