Rick Lapointe has been appointed president of HollisterStier Laboratories’ Contract Manufacturing unit, responsible for overseeing business development, manufactur¬ing, engineering, validation and process development functions. Mr. Lapointe is the chair of the Contract Op¬erating Committee and reports directly to chief executive officer Anthony D. Bonanzino, Ph.D. He has served as senior vice president of operations for HollisterStier since 2004 and previously worked for Burroughs Wellcome.  

Catalent Pharma Solutions

3Q Revenues: $453.3 million (+4%)

3Q Loss: $31 million (earnings were $21.8 million in 1Q07)

YTD Revenues: $1.4 billion (+8%)

YTD Loss: $72.5 million (earnings were $41.4 million YTD07)

Comments: The company attributed its revenue growth primarily to the effect of a weaker dollar. Without that factor, net revenues would have declined 2%, due primarily to lower North American volumes in printed components and commercial packaging. Sterile Technologies revenue was $76.7 million (+18%) in the quarter and $221.3 million YTD (+22%), thanks in part to the company's new steriles facility in Brussels. Packaging Services revenue was $125.3 million (-12%) in the quarter and $410.7 million YTD (-1%). SG&A expenses were $80.1 million (+21%) in the quarter and $238.6 million YTD (+11%).

HollisterStier Laboratories has completed the construction of a full-service 6,000-sq.-ft. lab  that includes analytical testing services with an analytical chemistry department. The lab is part of the company’s $42 million, 71,000-sq.-ft. facility-wide expansion project that more than doubles current manufacturing capacity.
   
The company has also expanded its 172,000-sq-.ft. facility to include a new Small Volume Parenterals (SVP) line to aseptically fill liquid and lyophi¬lized pharmaceutical products in vials ranging from 2mL through 200 mL in batch sizes from 20 to 3,000 liters.
   
The new line (SVP II) houses a 25,500-sq.-ft. vial filling complex with a Bosch FLC 3080 vial filler equipped with a nondestructive automatic check weigh system, diaphragm filling pumps and speeds as high as 400 vpm. The line offers multiple options for compounding including aseptic compounding, portable compounding vessels, and large fixed compounding tanks. The vial inspection and packaging area includes inspection, labeling, Ink Jet coding and secondary packaging.
   
SVP II is designed for multi-product manufacturing, both commercial and clinical trial material, with one product manufactured in the area at a time. SVP II includes advances in pharmaceutical technology such as automated non-destructive fill checks and ISO5 oversealing. In addition, two GEA lyophiliz¬ers will be added in a new ISO5/6 facility and ready for production in 1Q09.
   
“The expansion of our facilities is a reflection of the successes that our organization has worked hard to achieve,” said Anthony Bonanzino, Ph.D., chief executive officer of HollisterStier. “We take pride in the quality and efficiency we provide our customers. Our reputation as world-class contract manufacturers has allowed for us to be in a position to expand upon our capabilities so that we can continue to best serve our customer-base.”

Prevalere Life Sciences has opened a new biotechnology lab at its Whitesboro, NY headquarters, enhancing the current 48,000-sq.-ft. facility and housing seven labs. The company transformed unfinished space into a 1,800-sq.-ft. immunoassay lab, where it will conduct pharmacokinetic and immunogenicity testing.
   
“Over the last six years that we have been working in the biotechnology field, we’ve seen many breakthrough therapies emerging, leading to increased demand from our clients that required an expansion in this area” said Dr. Mario Rocci, Jr., Prevalere's chief executive officer. “We see this expansion as another opportunity to advance our mission of providing innovative R&D services to meet the evolving needs of the pharmaceutical and biotechnology communities.”
   
This expansion is considered to be Phase I of a two-phase project to meet future demand increases with a second new lab that could be up and running within 60 days. Prevalere has relocated its current team of immunoassay scientists to this new wing of the facility, and plans to hire more scientists in this area. Twenty employees were added in 2007, and seven more employees have been added this year to date.

Forest Laboratories and Daiichi Sankyo have terminated their co-promotion agreement for AZOR (amlodipine and olmesartan medoxomil), Daiichi Sankyo's fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil. Daiichi Sankyo will receive a one-time payment of $44.1 million from Forest Labs related to the termination. Beginning July 1, 2008, Daiichi Sankyo will be responsible for the promotion of AZOR.
   
A second agreement between the two companies, under which Forest co-promotes Benicar and Benicar HCT, has been extended to end on May 31, 2008. Also, there will be a residual period where Forest will continue to receive income from Benicar and Benicar HCT profits, which is not set to expire until March 31, 2014.
   
Howard Solomon, chairman and chief executive officer of Forest, commented, "We have enjoyed a very fruitful partnership with Daiichi Sankyo since our initial collaboration of Benicar, which began in 2002. Our decision to reallocate resources to our currently marketed products causes us to forego the opportunity to continue to participate in the promotion of Daiichi Sankyo's excellent product AZOR."
   
Daiichi Sankyo president and chief executive officer, Joseph P. Pieroni said, "Our first co-promotion agreement with Forest provided us with important additional resources to build our franchise of Benicar and Benicar HCT into significant products in the antihypertensive market while we built our own sales force. Our second co-promotion collaboration for AZOR allowed us to quickly and comprehensively educate the medical community about this new combination antihypertensive. Now we can take over full responsibility for the continued success of these brands."

Takeda  FY Results (April 1, 2007 – March 31, 2008)

FY Revenues: $13.9 billion (+5%)

FY Earnings: $3.6 billion (+6%)

Comments: FY growth was driven by Actos sales of $4.0 billion (+18%) and Candesartan/Blopress sales of $2.2 billion (+8%). Lansoprazole sales were $1.5 billion (-1%). Leuprorelin sales were $1.3 billion (-3%). Operating income was $4.1 billion (-8%). R&D expenses were up 43% due to enhancement of R&D activities, in-licensing and alliance activities, including the termination of a license agreement with Amgen.

Takeda Global R&D Center and Affymax achieved positive 12-month data from their ongoing Phase II trial evaluating the safety and tolerability of Hematide, an investigational drug in development for the treatment of anemia associated with chronic kidney disease (CKD). Preliminary trial data showed that Hematide administered once every four weeks was well tolerated and maintained mean hemoglobin levels between 11 and 12 g/dL in patients with CKD, both pre-dialysis and hemodialysis, over a 12-month period.  
   
The companies also announced the results of two other Hematide studies. One assessed safety and tolerability of the compound in CKD, for patients already on hemodialysis, and the other studied Hematide in CKD patients with Pure Red Cell Aplasia (PRCA), a rare but serious condition in which the body produces antibodies to erythropoiesis stimulating agents (ESAs) and the patient’s endogenous erythropoietin. Patients who develop PRCA are usually transfusion-dependent. In this study, treatment of these patients with Hematide resulted in maintenance of hemoglobin levels within target in the absence of transfusions.
   
Dr. David Recker, senior vice president, Clinical Sciences at Takeda said, “The focus for Takeda and Affymax are the needs of patients, which is at the forefront of drug development. Together, we are working to bring this novel potential treatment option to patients with CKD-induced anemia and to the physicians who treat them.”

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. received approval from the FDA for updated labeling for Abilify as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults. Abilify has been approved as a monotherapy for the treatment Bipolar I Disorder in adults since September 2004.
   
The approval of Abilify used in combination with lithium or valproate is based on results from a six-week, randomized, double-blind, placebo-controlled study in adults with manic or mixed episodes of Bipolar I Disorder who had an inadequate response to a two-week, lead-in phase of mood stabilizer monotherapy (lithium or valproate). The study showed that add-on Abilify was superior to lithium or valproate with adjunctive placebo in the reduction of the Young-Mania Rating Scale (Y-MRS) Total Score and the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score for Mania.
   
The FDA also approved a new recommended starting and target dose of 15 mg daily for Abilify monotherapy in the treatment of Bipolar I Disorder in adults. This approval is based on results from two randomized, double-blind, placebo-controlled studies in adults with manic or mixed episodes of Bipolar I Disorder. The study showed that Abilify was superior to placebo in the reduction of the Y-MRS Total Score and CGI-BP Severity of Illness Score for Mania.

Draxis Health

1Q Revenues: $19.2 million  (-9%)

1Q Loss: $2.4 million (earnings were $2.5 million in 1Q07)

Comments: Contract manufacturing revenues were $12.6 million (-11%) due to lower revenues of Genzyme's Hectorol. Sterile products represented approximately 65% of manufacturing revenues compared to 78% in 1Q07. Radiopharmaceutical sales were $6.1 million (+6%). The increase was primarily a result of the inclusion in revenues of a chargeback for freight services beginning on April 1, 2007. 1Q07 earnings benefited from milestone payments of $0.8 million from Shire BioChem, Inc. and $0.5 million from a business interruption insurance claim.

Eurand

1Q Revenues: $24.9 million (+24%)

1Q Loss: $1.6 million (loss of $1.2 million in 1Q07)

Comments: Product sales were $32.0 million (+17%). Royalties were $2.7 million (+103%). R&D expenses were $7.1 million (+21%). Revenues include $1.4 million from the Source CF acquisition.

Enzon Pharmaceuticals, Inc. announced plans to spin off its biotechnology business into an independent company focusing on the development of cancer treatments. Enzon will fund the new company with $150 million, which is expected to provide two to three years of R&D activity. The transaction, which is subject to approval from Enzon's board of directors, is expected to close in the fourth quarter.
   
Jeffrey H. Buchalter, Enzon's chief executive officer, will head the new company and Enzon's current chief financial officer, Craig Tooman will be responsible for the specialty pharmaceuticals business. Each company will have separate management teams.
   
"By separating these unique businesses into two focused companies, the opportunities for both the specialty pharmaceutical business and the biotechnology business could be substantially enhanced and greater value could be created than under the current structure," said Mr. Buchalter.
   
Enzon will also retain rights to its currently marketed drugs, which include Oncaspar for leukemia, Depocyt for meningitis, Abelcet for fungal infections and Adagen for severe combined immunodeficiency disease. In addition, it will retain rights to its royalty revenues.
   
The company also recently reported 1Q08 results. Revenues were $48.8 million (+18%). Earnings were $1.5 million compared to a loss of $2.8 million in 1Q07.

Quintiles Transnational Corp. has signed an agreement to acquire Eidetics, a privately held consulting firm located in Boston. Eidetics provides research-based market insights and data analytics to support business decision making in drug development and commercialization. No purchase price was disclosed.
   
The acquisition of expands Quintiles' consulting offerings in the areas of product development, commercialization and market access. Quintiles is expanding its consulting practices in an effort to help its pharmaceutical, biotech and medical device clients navigate the complex business environment.
   
"The addition of Eidetics to our Quintiles Consulting business will further strengthen our ability to provide our clients with distinctive, data-driven, strategic solutions to their toughest challenges throughout the product lifecycle," said Jay Norman, president, Quintiles Consulting.
   
"We are excited about the opportunity to become part of the Quintiles organization," said Jim Kirk, partner at Eidetics. "We believe that joining Quintiles Consulting will build upon the past success of Eidetics' business, while providing our clients enhanced clinical, patient and provider data, greater therapeutic depth and access to global resources."

Eli Lilly and Co. received approval from the FDA for Strattera for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant to treat ADHD in children, adolescents and adults.
   
The safety and efficacy of Strattera in the maintenance of ADHD was demonstrated in an 18-month trial of about 600 pateints aged six to 15 years, who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for ADHD. The study showed Strattera was superior to placebo in maintaining continuous efficacy in patients, as measured by the ADHD Rating Scale (ADHD-RS). Additionally, patients taking Strattera had lower relapse rates (3%) as compared to patients taking placebo (12%). Strattera was generally well tolerated. The most common side effects reported in the study were headache and the common cold (nasopharyngitis).  

MedImmune it has enhanced its leadership team to guide the company's expanded product pipeline and core scientific research. Jacqueline Hall has been appointed global vice president, product development team leadership; Lorin Roskos, Ph.D. has been appointed vice president and global head of pharmacokinetics (PK), pharmacodynamics (PD), and bioanalysis in translational sciences, and Beth Wensley has been appointed vice president, project management. In addition, Erik-Jan Dekker, Ph.D. joined the organization as vice president, international regulatory affairs, vaccines, and Reginald Seeto, M.D., joins as vice president, global strategic marketing and portfolio management.

"It is imperative that we have strong leaders who can channel the  
continued growth of our product portfolio, particularly as we seek to  
build out the organization globally," said David M. Mott, chief  
executive officer and president. "Jacqui, Lorin, Beth, E-J and Reg  
have the innate talent, industry experience and drive for results that  
will contribute to MedImmune's continued leadership in biologics."

Based at the Cambridge, UK site, Ms. Hall is responsible for the  
strategic leadership of global product development teams that are  
responsible for the generation and execution of development plans for biologics products. She joined Cambridge Antibody Technology (CAT), now MedImmune, in 2006 as vice president, project management. Previously, Ms. Hall served as project leader at GlaxoSmithKline where she was responsible for the strategic development of product candidates from selection through to market launch. She has also held positions at SmithKline Beecham, Pharmaco-LSR and Schering-Plough.

Dr. Roskos is responsible for managing and integrating preclinical and clinical PK/PD and bioanalytical groups at the company's sites in MD, CA and in England. Dr. Roskos joined the company in 2008 after a year at AstraZeneca as executive director of R&D. Dr. Roskos had previously spent six years at Abgenix, Inc., as the head of PK and toxicology, and has prior experience in PK and drug metabolism at Amgen and Eli Lilly.

Ms. Wensley oversees the global project management team that provides strategic project management in driving forward the product development teams and the overall product development portfolio. Ms. Wensley joined MedImmune in 2001, and has previously served as senior director, CA operations; director, supply chain operations; and associate director, project management.

Based in the Netherlands as the company's new vice president,  
international regulatory affairs, vaccines, Dr. Dekker will lead  
MedImmune's expansion overseas. In his previous position at Baxter  
Healthcare, he was the global senior director, regulatory affairs,  
biologics, responsible for worldwide vaccine and biosurgery marketing authorization applications. Prior to Baxter, Dr. Dekker was the director of regulatory affairs globally at Laboratoire Francais du  
Fractionnement et des Biotechnologies in France.

Dr. Reginald Seeto is responsible for providing strategic guidance on investment decisions and managing commercialization efforts for new products in various stages of development. In his previous position at Organon International, he was the vice president of global marketing, fertility, immunology, oncology and vaccines. Previously, Dr. Seeto was the executive director of marketing at Boehringer Ingelheim Pharmaceuticals and served as an engagement manager at McKinsey & Co.

Hospira

1Q Revenues: $888.7 million (+14%)

1Q Earnings: $65.4 million (loss of $29.4 million 1Q07)

Comments: In the Americas, pharmaceuticals revenues grew was 11% to $462.6 million. However, the "Other Pharmaceuticals" unit, which  
includes injectables and contract revenues, dropped 3% to $121.9  
million. Asia Pacific pharmaceuticals revenue was $49.7 million  
(+58%). 1Q07 loss includes $66.2 million of acquired in-process R&D  
charges related to the Mayne Pharma acquisition.