News in brief, July 04, 2007

Financial news

PregLem raises USD 26m
PregLem, a Switzerland-based pharmaceutical company, has collected USD 26m in Series A funding, which the company says will help develop and commercialise compounds for women suffering from infertility. Sofinnova Partners, a French investment firm, led the Series A round, joined by additional backers Norway-based NeoMed Management and Bostonís MVM Life Science Partners. According to a 2006 report by the London-based financial firm Spectra Intelligence, the US infertility drug market will grow to USD 9.9bn (EUR 7.3bn) by 2012. PregLem estimates its current EU market to be EUR 1.2bn (USD 1.6bn). PregLem also announced a licensing agreement with French pharmaceutical company Ipsen. PregLem will have worldwide development and commercialisation rights to certain Ipsen compounds. Other details of the agreement were undisclosed. PregLem did say that the Series A funds will be used to expand Ipsen compounds to the treatment of infertility disorders and aid in the development of new infertility compounds in early stage research R&D.

Traders move over to pharmaceutical stocks
According to a report in the UK newspaper, The Independent, the downturn in the FTSE 100 has seen traders exchanging high risk for defensive stock in blue-chip pharmaceutical companies. GlaxoSmithKline (GSK) and Shire saw their shares rise strongly on 27 June, but AstraZeneca (AZ) was the top performer, finishing up GBP 0.76 (USD 1.53) to rest at GBP 26.59 (USD 53.64). The FTSE 100 continued its decline from the previous day, falling nearly 63 points in a.m. trading, before closing 31.7 down. The pharmaceutical sector was also positive in the second tier, as Hikma Pharmaceuticals increased GBP 0.11 (USD 0.22) to reach GBP 3.75 (USD 7.57), after it released a trading statement ahead of expectations. The company said it expected H1 FY07 revenues to increase 40 per cent. Another stock that had the market excited was the Manchester-based IT firm Red Squared, which announced its first public health sector contract win with pharmacy technology company, Cegedim. At the same time it announced it had reversed losses to return a pre-tax profit of GBP 0.06 (USD 0.12) for H1 FY07, while stock finished up 17 per cent at GBP 9.50 (USD 19.17).

Costs push up Angel Biotechnology pre-tax losses for FY06
UK-based biomanufacturing company, Angel Biotechnology, has revealed that FY06 pre-tax losses widened compared with FY05. The firmís 67 per cent sales growth was offset by delays in securing orders and increased net operating expenses. The company said pre-tax losses for FY06 were GBP 2.5m, compared with a loss of GBP 1m in FY05, while sales rose to GBP 1.9m from GBP 1.1m. Its net operating expenses increased to GBP 2.2m from GBP 1.2m. Angel Biotechnology added that delays in securing orders for the Cramlington facility and related cost burdens led to the decision to close the facility. The company expects to return to profit following its decision to transfer all manufacturing to its Pentlands facility, which will reduce the cost base by an estimated 75 per cent.

Millennium shares rise on positive blood cancer drug studies
Millennium Pharmaceuticals has revealed positive early-stage study results for its drug Velcade (bortezomib), which may push the company ahead of its larger biotech rival, Celgene. Millennium's stock rose more than two per cent on the news, when the company reported clinical progress at the International Myeloma Workshop in Greece. The reports included a small, early-stage study which examined how Velcade worked in combination with Revlimid (lenalidomide) in newly-diagnosed patients who had not been previously treated for multiple myeloma. The company reported that the combination stopped the spread of cancer in 13 of 15 patients. A Millennium spokesman said that Velcade could someday be combined with Revlimid, if further tests were successful. Millennium also reported that Velcade combined with the generic cancer drugs melphalan and prednisone, completely stopped the spread of multiple myeloma in 43 per cent of patients over 38 months. Sales for Velcade, which entered the US market in 2003, totalled USD 58m in Q1 FY07, and Millennium projects sales of USD 240m to USD 260m (EUR 176.3m to EUR 191m) for FY07. Millennium partnered with the drug giant Johnson & Johnson to develop the drug. Sales for Celgene's Revlimid were boosted on 15 June when it was approved to treat multiple myeloma in the EU. Revlimid sales totalled USD 320m in FY06, while sales for Celgene's other multiple myeloma drug, Thalomid (thalidomide), racked up USD 433m in the same time period.

Koronis and Targeted Genetics win venture capital funding
Koronis Pharmaceuticals has received USD 20m in venture financing from Pacific Horizon Ventures and the Asset Management Company. The US-based biotechnology company said it planned to use the money to conduct two clinical trials on the effectiveness of its leading product candidate, a novel anti-HIV treatment in humans. Koronis expects to conclude the trials in 2008. The therapy, already determined to be safe in humans, has shown effectiveness in a lab setting during preclinical trials, the privately-owned company revealed. It seeks to annihilate HIV infections by encouraging mutations that make the virus unfit to reproduce. The company said it was enrolling patients in the first trial. Simultaneously, Targeted Genetics has completed a private-equity placement of USD 17.8m in net proceeds. The lead investor was Special Situations Fund, while other investors were Fort Mason Partners and Heights Capital Management. The financing will help fund clinical trials and pursue business-development opportunities, said CEO H Stewart Parker. Targeted Genetics specialises in developing targeted molecular therapies to treat diseases such as inflammatory arthritis, AIDS and congestive heart failure.

Biotechnology stocks jump
Biotechnology stocks rose on 27 June on a mix of positive news from small and large companies alike, as the overall market showed slight gains. Genentech and Cephalon presented their pipeline development overviews during the second day of Jefferies' health care conference. The American Stock Exchange's biotechnology index rose 16.73 points, or 2.2 per cent, to reach 781.76. The NASDAQ Stock Market's biotechnology index, which covers a broader range of small- and mid-cap stocks, rose 15.32 points, or nearly two per cent, to rest at 810.79. Genentech rose USD 1.74 (2.4 per cent) to USD 74.34; Biogen was up USD 1.21 (2.3 per cent) to USD 53.57; Genzyme climbed USD 1.24 (two per cent) to USD 65.96; Cephalon increased USD 3.29 (4.3 per cent) to USD 80.10; Amgen rose USD 0.40 to USD 55.50; Vertex Pharmaceuticals were up USD 1.71 (6.5 per cent) to USD 28.10; and Verenium climbed USD 0.87 (20 per cent) to USD 5.25.

Collaborations news

pSivida signs agreement for nanotech cardiovascular drug delivery
Australia-based drug delivery company, pSivida, has entered into an evaluation agreement with an undisclosed large global medical device company to evaluate cardiovascular delivery of drugs using pSividaís drug delivery technologies. pSivida is a global bio-nanotech company focused on the biomedical sector and the development of drug delivery products. pSivida owns the rights to develop and commercialise a modified form of silicon (porosified or nano-structured silicon) known as BioSilico, which has applications in drug delivery, wound healing, orthopaedics and tissue engineering. The most advanced BioSilicon product, BrachySil delivers a therapeutic, P32 directly to solid tumours and is presently in phase II clinical trials for the treatment of pancreatic cancer. In April 2007, the company signed an exclusive worldwide research and license agreement with US drug giant, Pfizer, for applications relating to pSividaís controlled drug delivery technology, Medidur, in ophthalmic applications.

SurModics and Merck & Co sign ophthalmic agreement
SurModics and Merck & Co have signed a license and research agreement to develop and commercialise products for the treatment of retinal diseases. The products will combine Merck's proprietary drug compounds with SurModics' I-vation sustained drug-delivery system. Merck will lead the development and commercialisation efforts and reimburse SurModics for its development costs. SurModics, which develops surface modification technology, will receive an up-front license fee of USD 20m and could receive up to an additional USD 288m in fees and development milestones. It will also get royalties on product sales. Shares of SurModics, which reported revenue of USD 69.9m for FY06, were down USD 0.17 to rest at USD 37.36 on 26 June, while Merck closed USD 0.78 higher at USD 49.12.

Hisun Pharma to form JV with Spanish company
Zhejiang Hisun Pharmaceutical, which is one of China's biggest active pharmaceutical ingredient producers, has signed a letter of intent with an unnamed Spanish company on drug research and development and marketing, according to local media reports.

Coley wins USD 5m marketing deal
US-based Coley Pharmaceutical Group has said it will receive at least USD 5m (EUR 3.7m) from Dynavax Technologies in return for rights to market an experimental vaccine. Dynavax will have a nonexclusive license to commercialise Coleyís hepatitis B vaccine, Heplisav. The vaccine is currently in phase III clinical trials, and Coley expects to submit it to the FDA in 2008. Coley is eligible for an additional USD 5m payment upon US approval of the vaccine. Shares of Coley fell USD 0.03 to USD 3.56 on 29 June.

Breckenridge and Chemo/Liconsa sign Lamisil agreement
US pharmaceutical company Breckenridge has signed an agreement with Spanish partner Chemo/Liconsa to develop and manufacturer terbinafine, which is a generic version of Novartisí antifungal treatment, Lamisil. Breckenridge signed a Letter of Intent in February 2007 to secure the marketing in the US for the ANDA; which is filed and pending FDA approval. FDA acknowledged the transfer of the ANDA to Breckenridge, and final approval is expected shortly. The global market for Lamisil is in excess of USD 800m (EUR 587.4m).

Medical education news

HES invites attendance for 2007 med ed courses
Healthcare Education Services (HES) has announced two additional opportunities to attend its ëIntroduction to Oncology and Chemotherapyí courses in 2007. The courses will both be held in November 2007, with one based in the UK and one in the US. Demand for places on these courses held in the Spring was high again in 2007 and in response HES has been successful in securing its expert speakers for a second ëIntroduction to Oncology and Chemotherapyí for each country as part of the Autumn 2007 schedule. Education Services Director, Valerie Smith, said: ìPositive feedback to the courses held earlier in the year has encouraged us to pull out all the stops and we have been extremely fortunate to be able to work with our speakers in the UK and the US to arrange some more dates.î HESí training courses are designed to provide high-quality education in a range of therapy areas and a variety of marketing issues. They are led by expert faculty and involve lectures, case discussions and group work, encouraging delegates to develop a thorough understanding of the topic concerned. The courses are ideal for both medical and non-medical staff within the pharmaceutical industry, including those from clinical research, medical information, regulatory affairs, biometrics and strategic marketing departments.

Company news

Advancis changes name to MiddleBrook
Advancis Pharmaceutical, a US-based pharmaceutical company, has changed its name to MiddleBrook Pharmaceuticals. The name change, effective immediately, was completed pursuant to the company's jointly submitted Permanent Injunction and Order with sanofi-aventis of 27 October 2006, whereby the company agreed to cease using the Advancis name by 30 June 2007. In conjunction with the new name, MiddleBrook will change its NASDAQ trading symbol to MBRK, effective with the start of trading on 29 June 2007. The company is also continuing its previously announced process to explore strategic alternatives and that process is ongoing.

Eli Lilly divests Distaclor antibiotic
The Indian subsidiary of global pharmaceutical major Eli Lilly has divested its antibiotic Distaclor (cefaclor) to Pharmalink, a subsidiary of Quintiles International, for an undisclosed sum, according to local media reports. Lilly has been marketing Distaclor in the country since 1993. The brand had annual sales of about INR 22m to INR 23m, according to a company statement. The divestment follows Lilly's global policy of phasing out legacy products, while concentrating on core speciality areas, such as diabetes.

Panacea Biotec enters oncology segment
Indian biotech company Panacea Biotec has revealed it will move into oncology segment, which is expected to contribute INR 15-20m (USD 0.4m ñ USD 0.5m) to the company's overall revenues in the next three years. The company said it would launch breast cancer, brain tumour, ovarian cancer, pancreatic cancer, prostate cancer and colorectal cancer drug, it said in a statement. Panacea added it would launch seven anti-cancer products in the next eight weeks, which would be manufactured by a Mumbai-based company. The company revealed it would float a strategic business unit, Oncotrust, with 50 sales specialists in oncology who would be responsible for marketing the drugs. The company would be able to launch novel drug delivery based anti-cancer drugs in next 2-3 years. The Indian oncology market presently stands at about INR 800m (USD 19.8m) and is growing at 22 per cent annually.

Grant to turn Pfizerís Michigan facility into biofuels research hub
The Michigan Economic Development Corporation has received a USD 3.4m grant from the stateís 21st Century Jobs Fund to transform the former Pfizer research facility in that state into a biofuels research centre. The Holland centre will feature research in the areas of biofuels, such as ethanol and biodiesel, is expected to open in January 2008. In January 2007, Pfizer announced it planned to close several of its facilities across Michigan, including the Holland plant. Lakeshore Advantage Corporation, a regional economic development agency and MEDC partner serving the Holland-Zeeland area, was selected to provide administrative support for the initiative. The 21st Century Jobs Fund is a USD 2bn programme designed to accelerate the diversification of Michiganís economy and encourage investment in life sciences, alternative energy, advanced automotive technology and homeland security.

Regulatory news

NICE launches CVD guidance
NICE is today consulting on new draft guidance on the primary and secondary prevention of cardiovascular disease (CVD). With the emphasis on improving cardiovascular risk assessment and modifying blood lipid levels, the guidance includes recommendations on lifestyle changes, such as modifying diet, smoking and exercise, and how drugs, including statins, can be used to improve lipid levels. NICE also recommend adopting a general approach to identifying those most at risk of developing CVD by looking at information routinely collected by GPís and using this to prioritise people for further assessment. The draft recommendations are available at www.nice.org.uk, while the consultation closes on 22 August 2007.

Wyeth starts marketing and distributing BeneFIX in the EU
The EU division of Wyeth has assumed all marketing and distribution rights to BeneFIX Coagulation Factor IX (Recombinant) in the EU. The transfer of responsibility follows the planned 30 June conclusion of a 10-year distribution rights agreement between Baxter Healthcare and Genetics Institute, which was acquired by Wyeth in 1996. Wyeth and Baxter representatives have worked together to ensure a structured transition between companies and an uninterrupted supply of BeneFIX to people with haemophilia B. In May 2007, Wyeth received a positive opinion from the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, on new convenience enhancements to BeneFIX. The product enhancements are a 2000 IU dosage strength vial, a needle-free reconstitution device, a pre-filled diluent syringe and a low five ml diluent volume for all dosage strengths.

Singapore agrees to tighter global rules on drug marketing
Pharmaceutical companies in Singapore have agreed to adopt stricter international guidelines on marketing, according to the Association of Pharmaceutical Industries. The decision was reached after conferring with counterparts from Asia, Europe and the Americas. The revised international code of pharmaceutical marketing practices devised by the International Federation of Pharmaceutical Manufacturers and Associations came into force in January 2007. The federation is a non-governmental organisation representing research-based pharmaceutical companies and national industry associations. Companies who break the code face association fees up to SGD 10,000 (USD 6,493).

Teva to sell generic version of Pfizer's Norvasc
Israeli pharmaceutical company Teva has said that the FDA has cleared its generic version of Pfizer's antihypertensive, Norvasc (amlodipine). Total annual sales of the drug are about USD 2.8bn, according to Teva. Before it went off patent, Norvasc was one of Pfizer's best-selling drugs, but the advent of generic copycats will erode sales dramatically. Rival US generic manufacturer Mylan launched a generic form of the medicine in March 2007, after a federal appeals court declared some of Pfizer's patent claims invalid. Mylan has sued US regulators, claiming it was entitled to the standard 180-day marketing exclusivity typically granted to the first generic drug on the US market. Later in May, privately owned Apotex said it had launched its own generic version. On 29 June, Mylanís shares dropped one per cent or USD 0.21 to rest at USD 18.16 in pm trading on the NYSE, while Teva shares were flat at USD 41.03 on NASDAQ. Pfizer shares were down USD 0.17, or 0.62 per cent, at USD 25.46 on the NYSE.

SFDA withdraws Parkinson's drug from Chinese market
The Chinese State Food and Drug Administration (SFDA) has withdrawn Eli Lillyís Celance (pergolide), a Parkinson's disease treatment, from the market due to potential risks of heart valve damage. The decision echoes the FDA move in March 2007 where companies manufacturing and distributing the US version, Permax, agreed to withdraw the drug from the market due to the risks. The US FDA decision was informed by two new studies that demonstrated that Parkinson's disease patients treated with Permax had an increased chance of serious heart valve damage, compared with patients who did not receive the drug. All production, sales and consumption of pergolide will cease from the beginning of 2008, according to the SFDA. Pergolide is a dopamine agonist and is combined with levodopa and carbidopa to control the symptoms of Parkinson's disease.

Glenmark wins FDA approval for cancer drug
India-based Glenmark Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for ondansetron and ondansetron oral disintegrating tablets. The products are generic versions of GlaxoSmithKline's (GSK) Zofran anti-emetic tablets and are used for prevention of nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery, according to a statement sent to the Bombay Stock Exchange. The company said its US unit will start marketing the product in the US. According to IMS Midas data, ondansetron tablets racked up annual US sales of about USD 744m.

People news

TrakHealth hires new director of worldwide markets
Australian-based healthcare solutions provider, TrakHealth, an InterSystems company, has appointed Darren Jones to the newly created position of director of worldwide markets. Jones, who will report to InterSystems' CEO, Terry Ragon, is responsible for managing worldwide sales activity for TrakHealth and for evaluating and planning entry into new countries. InterSystems, whose products provide the premier platform for connected healthcare, recently acquired TrakHealth, which develops and markets the TrakCare web-based healthcare information system. Jones has over 20 years of healthcare IT experience in vendor and delivery organisations, with roles encompassing all aspects of IT, including development, implementation, support services, sales and business development. Jones joined TrakHealth in 2001 and was most recently the company's Asia-Pacific regional director. Prior to joining TrakHealth, Jones worked for six years at IBA Health, rising to the position of Australia & New Zealand general manager.

Wyeth elects new senior vice-president of finance
Wyeth has promoted Mary Katherine Wold to the position of senior vice-president of finance. Wold will report to Greg Norden, who is Wyeth's new CFO. Wold joined Wyeth as vice-president of taxes in 2002. In 2005, she assumed the position of senior vice-president of tax and treasury.  Prior to joining Wyeth, Wold was a partner in the New York law firm of Shearman & Sterling beginning in 1988 and was the head of its worldwide tax practice group from 1995 through 2000.

Centron hires med ed leader
Centron, a US-based medical communications company, has hired Janice Gelfond as executive vice-president and managing director of its medical education division. Gelfond, who has over 25 years experience in the medical education arena, will provide strategic leadership in the development of communication plans for pharmaceutical brands. Prior to joining Centron, Gelfond served as senior vice-president and managing director of Cerebrio, a med ed company within the Corbett Accel Healthcare Group.

Cook Pharmica hires two vice-presidents
Cook Pharmica, a US-based company specialising in manufacturing mammalian cell culture-based pharmaceuticals, has hired Connie Degen as vice-president of operations and Tedd Green as vice-president of business operations and CFO. In her new role, Degen will be responsible for directing and overseeing manufacturing activities. She had been in the role of director of operations until her promotion, and before that was quality director at Baxter Pharmaceutical Solutions. Green joined Cook Pharmica two years ago after serving as a senior business analyst for Eli Lilly where he was responsible for providing general business support to Lilly's business-to-business operations. In his new dual role, Green will be responsible for overseeing the financial, human resource, project management, business development and marketing programmes, policies and services.

Cytovance expands sales and business development team
US-based company last week hired Michael Faughnan to lead the team to meet growing demand for the company's unique services portfolio. Faughnan is responsible for leading sales and business development efforts in western North America, including introducing key prospects to Cytovance's comprehensive range of process development and cGMP manufacturing services, as well as the company's portfolio of technical and strategic support services. Prior to joining the Cytovance management team, Faughnan spent five years at Irvine Scientific in California as territory manager, where he managed accounts for industrial and academic cell culture media and serum sales.

New vice-president for BioStorage Technologies
BioStorage Technologies (BST), which specialises in biomaterials storage, sample management and cold chain logistics, has hired James Saponaro as executive vice president. Saponaro, who is a long-time Cardinal Health executive, will oversee the company's sales and marketing, operations, information technology and business development functions.

Xceleron appoints first COO
Xceleron, a US-based analytical strategy company focusing on drug development, has hired Bernard Chan as its COO. Dr Chan adds depth to Xceleronís management team by bringing valuable know-how gained from 18 years experience in the pharmaceutical and biotech industry. Chan was most recently Director of Biological Manufacturing Development at UCB Pharma for a total of four years and has also held senior management roles at Medeva and Delta Biotechnology. He also co-founded Eden Biopharm, an international development and manufacturing consultancy.

PRA names new vice-president and CFO
Clinical research organisation PRA International has also made a senior management change recently, naming Linda Baddour executive vice-president and CFO. Baddour replaces Matt Bond, who resigned to pursue other opportunities. She was previously CFO at Pharmaceutical Product Development (PPD). The announcement comes just a month after the PRA named both a new president and a CEO. The company appointed Terrance Bieker as CEO having filled the position as an interim since December 2006, and named Colin Shannon, who also used to work for PPD, as president and COO.

Draxis hires new vice-president of commercial and business development
In other news, contract manufacturer Draxis Pharma has appointed Bruce DeChambre as vice president of commercial and business development. DeChambre will be in charge of identifying prospective customers and developing new business opportunities within the pharma sector while maintaining quality services to its existing clients. DeChambre was a pharmaceutical industry consultant to investment firms and healthcare advertising agencies, and previously worked SAB-Pharma, which was recently acquired by Novartis, and Cardinal Health.

MDS Pharma hires new vice-president of IT
MDS Pharma Services has named Howard Moody vice president of information technology (IT). In his new role, Moody will be responsible for implementing effective IT applications to improve processes and fuel business growth in the company. Before joining MDS, Moody was chief information officer at Medifacts International, a CRO based in Maryland, where he was responsible for global IT. He also spent five years at Covance as chief information officer and senior vice-president.

Wyeth reveals new CFO
Robert Essner, Chairman and CEO of Wyeth, has revealed the election of Greg Norden, to the position of Senior Vice President and CFO of Wyeth. Norden, who was previously executive vice-president and CFO at Wyeth, has been with the company since 1989. He has held positions of increasing responsibility, including senior vice-president of finance and CFO for American Home Food Products and senior vice-president and CFO for Wyeth Laboratories.  He served as executive vice-president and CFO for Wyeth since 2000. Prior to Wyeth, Norden was employed by Arthur Andersen & Company in New York.  He succeeds Kenneth J Martin, who had previously announced his plans to leave the company effective 30 June 2007.