Pharma M&As

Excellent report on Pharma M&As in 2007
http://pharmexec.findpharma.com/pharmexec/Articles/2007-in-MampA-44-deals-79-billion/ArticleStandard/Article/detail/507989?contextCategoryId=43700

J&J to cut 400!

As per FirstWord, Johnson & Johnson announced plans to consolidate marketing and sales operations of subsidiaries Ortho Biotech and Centocor, in response to declining sales of anaemia drug Procrit amidst safety concerns. The move is expected to result in the elimination of between 400 and 450 jobs by the end of the year.
Kim Taylor, current president of commercial operations for Ortho Biotech, has been selected to head the merged sales and marketing force, which will be located at Centocor’s headquarters in Pennsylvania. The company expects to begin transitioning personnel to the new headquarters in September

Bayer's Zevalin

Bayer says that it has won an extended approval from the European Commission for its radioimmunotherapy treatment Zevalin.The green light means that Zevalin ([90Y]-ibritumomab tiuxetan) can be used in the course of a first-line therapy after remission induction in previously untreated patients with follicular lymphoma. The drug has been approved for adult patients with rituximab-relapsed or refractory CD20-positive follicular B-cell non-Hodgkin’s lymphoma since 2004.The approval is based on data from a Phase III trial which showed that, when used as first-line consolidation therapy - which is given after a patient responds to a first-line induction therapy, ie chemotherapy, Zevalin significantly prolonged progression-free survival time from 13.5 months to 37 months.Anton Hagenbeek of the Academic Medical Centre, Amsterdam, and lead investigator of the aforementioned trial, said “it is particularly impressive that with one single infusion of Zevalin, we have achieved prolongation of median progression-free survival by two years, with a favourable toxicity profile”. He added that the results show radioimmunotherapy “is a very effective single agent in the treatment of follicular lymphoma”, which is one of the most common types of indolent NHL.Encouraging AMD data for VEGF Trap-EyeBayer has also presented encouraging 32-week follow-up results from a Phase II study of its vascular endothelial growth factor blocker, VEGF Trap-Eye, in age-related macular degeneration, the leading cause of blindness for people over 65 in the USA and Europe.The data, which was presented at Association for Research in Vision and Ophthalmology meeting in Fort Lauderdale, demonstrated that patients on VEGF Trap-Eye – which is being developed with Regeneron Pharmaceuticals – achieved a 6.6 mean letter gain in visual acuity versus baseline at week 16 following 12 weeks of fixed dosing, which was maintained to week 32. The decrease in retinal thickness was also maintained for all dose groups at 32 weeks.Bayer and Regeneron are hoping that VEGF Trap-Eye will become a strong competitor to Genentech’s Lucentis (ranibizumab) and the two companies are carrying out two Phase III trials comparing the two compounds.

Merck's Cordaptive in News

In a blow to the drugmaker, the agency has issued a non-approvable letter for Cordaptive, which Merck hoped would revive its cholesterol franchise, now that Zocor is beset by generic rivals and Vytorin is under siege due to the controversial Enhance study.
Instead, Merck execs are scurrying to understand the FDA decision, which the drugmaker failed to reveal. “We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile,” Peter Kim, Merck’s chief scientist, says in a statement. Abbott must be happy - its Simcor pill was approved two months ago.
The pill contains an extended-release form of niacin, which is a vitamin, and a chemical called laropiprant to stop flushing, a dilation of blood vessels that causes redness and an unpleasant burning sensation on the neck and face. Flushing is a common side effect of niacin-based drugs, and the biggest reason many patients stop taking current products, including Niaspan.
Merck hoped to market Cordaptive as a way to reducing facial flushing while simultaneously lowering LDL, or bad cholesterol, and raising HDL, or good cholesterol. Given the failure of Pfizer’s torcetrapib, some docs expressed skepticism last year over the prospects for Cordaptive. The Pfizer pill caused unexpected deaths, and a recent Cordpative study revealed an increase in liver enzymes and had an impact blood sugar for diabetics.
At the same time, Committee for Medicinal Products for Human Use recommended approval in Europe. And though some investors remained concerned about risks to blood platelets, some Wall Street analysts expected FDA approval; Sanford Bernstein’s Tim Anderson, for instance, forecast $808 million in sales by 2012.

Merck in News (29 April 2008)

Singulair: Merck & Co., Schering-Plough receive FDA not-approvable letter for combination allergy treatmentMerck & Co. and Schering-Plough announced that they received a not-approvable letter from the FDA for an allergy treatment that combines Merck’s Singulair (montelukast) with Schering-Plough’s Claritin (loratadine) in a single tablet.
The companies' joint venture, Schering-Plough/Merck Pharmaceuticals, indicated that it is evaluating the agency’s response but did not provide further details. Schering-Plough spokesperson Lisa Ellen added that “we’re…still evaluating the future of the joint venture as well.”

Fosamax increases risk of atrial fibrillation, study suggestsResults from a study published in the Archives of Internal Medicine suggest that women taking Merck & Co.'s osteoporosis drug Fosamax (alendronate) had a higher risk of atrial fibrillation, compared with those who did not receive the drug.
In the study, researchers examined data from 719 women with a confirmed atrial fibrillation incident between October 2001 and December 2004, as well as data from 966 women without atrial fibrillation. Study lead researcher Susan Heckbert noted that the findings showed that "having ever used alendronate was associated with an 86-percent higher risk of newly detected atrial fibrillation compared with never having used the drug." Nonetheless, Heckbert commented that the benefits of bisphosphonates such as Fosamax generally outweigh the risks for patients at high risk of fractures.
In response, a spokesperson for Merck noted that a recent study published in the BMJ showed no evidence linking the use of bisphosphonates to an increased risk of atrial fibrillation

Wyeth Lays Off Another 1,200 Employees

The drugmaker last Friday notified employees that still more jobs are going, a Wyeth spokesman confirms. This follows an announcement last month that 1,240 sales positions would be eliminated as part of what Wyeth execs are calling ‘Project Impact.’
The moves come as Wyeth grapples with various problems. Although the FDA recently approved the Pristiq antidepressant, the drugmaker has otherwise run into one setback after another in winning permission to market other drugs. Over the past year, the FDA has bounced a drug, demanded more data or a new patient study. Meanwhile, Wyeth expects generic competition for the Protonix heartburn med, one of its biggest sellers with sales of $1.9 billion.
Prior to the cutbacks, Wyeth execs acknowledged plans to eliminate 4 percent of its global workforce of appoximately 50,000 people by mid-year and 6 percent by year’s end. The latest cuts were made among employees “in all capacities,” the spokesman says, while declining to confirm that the Fort Dodge animal health business was spared. As we have already pointed out, 141 jobs were eliminated at Wyeth’s Pearl River, New York, plant as part of the latest round of layoffs.

Viread Approved for Hep B in EU

EU grants approval for Gilead's Viread in hepatitis Bby Bryan DeBusk
Gilead announced that the European Commission granted marketing authorisation for once-daily Viread (tenofovir disoproxil fumarate) as a treatment for chronic hepatitis B.
The drugmaker noted that the decision was based primarily on data from two ongoing Phase III trials examining the safety, tolerability and efficacy of the drug compared with Gilead's Hepsera in patients with the disease.
The company also indicated that applications are pending in the US, Canada and Australia for the use of Viread in chronic hepatitis B

GSK to acquire Sirtris for USD 720 MM

GlaxoSmithKline reported that it entered into an agreement to purchase Sirtris Pharmaceuticals for $22.50 per share in a transaction valued at about $720 million. GlaxoSmithKline said the deal is expected to boost its metabolic, neurology, immunology and inflammation research efforts.
Sirtris' lead drug candidate, SRT501, is currently in Phase II testing for diabetes, with results anticipated later this year.

Wyeth and ViroPharma halt development of thier HCV candidate

Wyeth and ViroPharma have decided to discontinue development of their hepatitis C drug HCV-796, after concerns about hepatotoxicity were raised during a Phase II trial last year.
CEO of ViroPharma Vincent Milano commented that "significant activities were undertaken to determine a clear path forward for HCV-796; however, the risk associated with potential hepatotoxicity ultimately posed too high of a hurdle to merit further development." ViroPharma also stated that the two companies do not plan to collaborate on future development of hepatitis C drugs

Ranbaxy could earn additional USD 1.5 billion in next 6 years

AstraZeneca entered into an agreement to settle US patent infringement litigation with Ranbaxy over Nexium. Under deal terms, Ranbaxy will be allowed to sell a generic version of Nexium under licence from AstraZeneca starting on May 27, 2014. Ranbaxy will have a 180-day period of exclusivity as the only distributor for generic Nexium, and conceded – as part of the agreement – that "all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable." No financial terms of the deal were disclosed.
In addition, the drugmakers entered into an agreement under which Ranbaxy will manufacture a portion of AstraZeneca's US supply of Nexium from May 2010, as well as the treatment's active ingredient from May 2009. Furthermore, the companies signed distribution deals that allow Ranbaxy to be the distributor for authorised generic versions of hypertension compound Plendil and proton pump inhibitor Prilosec in the US.
Ranbaxy CEO Malvinder Singh stated that the agreements with AstraZeneca could earn as much as $1.5 billion in revenue over the next six years

Nektar to Cut 20 Percent of Work Force

SAN CARLOS, Calif. — Biopharmaceutical company Nektar Therapeutics said Tuesday it cut about 150 employees, or roughly 20 percent of its work force, as part of a restructuring plan and said its Chief Operating Officer Dr. Hoyoung Huh will step down.
Nektar said the restructuring plan is designed to complete the company's transition from providing drug delivery services to developing therapeutic drugs.
According to a filing with the Securities and Exchange Commission Tuesday, the job cuts include about 110 full-time staff and around 40 open positions. The company notified the affected employees Monday.
Nektar estimates a pretax restructuring charge in 2008 of about $7 million to $8 million, mostly related to one-time severance costs.
Separately, the company said Tuesday that Huh, who also was head of the company's PEGylation business, will serve on Nektar's board of directors.
In May, Nektar said it would cut 25 percent of its work force to reduce costs

Pharma News Updates: Jan 15, 2008

Genentech's Avastin sales miss expectations in fourth quarter
Genentech reported Monday that its fourth-quarter net income rose 6 percent to $632 million over the year-ago period. Avastin's quarterly sales climbed 23 percent to $603 million, but fell short of analysts' expectations of $616 million.
Rituxan's fourth-quarter sales rose 6 percent to $596 million, while Herceptin's revenue climbed 2 percent to $327 million. Lucentis' quarterly sales were $197 million, a 9-percent decrease compared with the year-ago quarter. Commenting on the results, Robert W. Baird's Christopher Raymond, stated: "It's not much to write home about -- they were light on product revenues." The analyst noted that "Avastin was light, and it's a key number," adding that both Rituxan and Herceptin's quarterly sales were also lower than Wall Street estimates. Total revenue for the quarter was in line with analysts' forecasts at $2.97 billion, compared with $2.71 billion in the year-ago quarter.
The company also reported full-year results, stating that net income rose 31 percent to $2.8 billion on revenue of $11.7 billion. Avastin's full-year sales rose 32 percent to $2.3 billion while Rituxan recorded a 10-percent increase in revenue to $2.3 billion for 2007. Sales of Herceptin were up 4 percent to $1.3 billion for the year.
Additionally, the drugmaker specified that it decided not to continue development of its topical VEGF product, telbermin, for diabetic foot ulcers, following negative Phase II results. Looking forward, CEO Arthur Levinson stated that in 2008, the company "will continue to invest in the 20 new molecular entities in clinical development and look forward to new data from a number of potentially important line extensions, including Rituxan for multiple sclerosis and lupus and Avastin in combination with Tarceva for advanced non-small-cell lung cancer."
FDA approves Tysabri for use in Crohn's disease
The FDA granted expanded approval to Elan and Biogen’s Tysabri for the treatment of Crohn’s disease, Elan announced Monday. The company indicated that the drug should be made available for patients with the disease by the end of February.
The product is now indicated in the US for adults with moderately-to-severely active Crohn's disease with evidence of inflammation and who have had an inadequate response to conventional therapies and TNF-alpha inhibitors. The drug will have a specific risk management plan for patients with Crohn's, Elan noted.
Tysabri, which is approved to treat multiple sclerosis in the US and EU, received a negative opinion in the EU for Crohn's disease last year.
France backs cervical cancer vaccination with Gardasil
France's High Council for Public Health on Monday announced that girls 14 years of age should be vaccinated with cervical cancer vaccine Gardasil. The vaccine, which is sold in Europe by Sanofi Pasteur MSD, a joint venture between Merck & Co. and sanofi-aventis, protects against four strains of human papillomavirus.
The agency, which said the vaccine should protect against four HPV strains, also suggested that vaccination should be offered to women aged 15 to 23 years either before, or within a year, of their first sexual contact. Gardasil competes against GlaxoSmithKline's Cervarix, which protects against two strains of HPV.
Novo Nordisk discontinues development of inhaled insulin, AERx
Novo Nordisk will discontinue development of its AERx inhalable insulin product and plans to eliminate jobs as a result, the company reported Monday. The drugmaker said the move follows an analysis of future medical and commercial prospects for inhaled insulin.
Mads Krogsgaard Thomsen, Novo Nordisk's chief scientific officer, stated that Pfizer's recent move to end sales of its inhalable insulin product, Exubera, prompted Novo Nordisk's decision. Meanwhile, company spokesperson Lori Moore stated that a "significant number" of the 360 workers at the drugmaker's plant in Hayward, California will lose their jobs as a result of the decision.
Novo Nordisk said it will take a charge of 1.3 billion Danish kroner ($260 million) in the fourth quarter related to AERx.

Pharma News Update: January 16, 2008

Fortune scolds Merck for "risky" programs
Fortune writer John Simons is taking Merck to task for two development programs he finds particularly risky. "The riskiest of Merck's current projects is taranabant," writes Simons, "a treatment that until recently was hailed as an elegant solution for attacking excess weight. Rather than working in the gut, taranabant manipulates the brain to suppress appetite. More specifically, the drug acts on the same receptors in the brain that cause marijuana-smokers to experience hunger. Taranabant, in essence, causes a patient to experience the reverse-munchies."
Psychiatric side effects could derail that program, says Fortune. The there's the cholesterol medicine, anacetripib, which bears far too close a resemblance for Simons to Pfizer's infamous torcetrapib. Towards the end of the piece there's at least one analyst willing to agree that Merck is taking big risks, but stands to gain enormous rewards. Sounds like the kind of bet the Big Pharma developers should make more often if they want to find a way to a brighter, richer future. The last thing biopharma needs now is an even more cautious approach to drug development
AstraZeneca launches head-to-head trial comparing Crestor and Lipitor
AstraZeneca on Tuesday announced the launch of a clinical trial to compare Crestor with Pfizer’s Lipitor for the treatment of atherosclerosis in patients with coronary artery disease.
The SATURN study will compare the 40-milligram dose of Crestor with the 80-milligram dose of Lipitor in about 1300 high-risk patients and is designed to measure the ability of the statins to decrease progression or induce regression of atherosclerosis, following two years of treatment.
The trial is expected to be completed in 2011, AstraZeneca noted
Forest's third-quarter profit up 21 percent on drug sales

Forest reported Tuesday that its profit in the third quarter rose 21 percent to $301.8 million over the prior-year quarter, on strong sales of Lexapro and Namenda. The drugmaker also raised its earnings forecast for its fiscal year ending March 31.

In the quarter, sales of Lexapro grew 11 percent to $603.5 million, while sales of Namenda jumped 26 percent to $218.7 million. Overall, third-quarter revenue was $998.2 million, a 12-percent increase over the same quarter in 2006, and higher than analysts' expectations of $947 million.

Regarding its pipeline, the drugmaker anticipates launching its recently approved hypertension drug, Bystolic, this month

HRT increases risk of lobular breast cancer, study
Study results suggest that combination hormone replacement therapy may raise the risk of lobular breast cancer after just three years. The findings are published in the January edition of Cancer Epidemiology, Biomarkers and Prevention.
"Previous research indicated that five or more years of combined hormone-therapy use was necessary to increase overall breast-cancer risk," noted lead researcher Christopher Li. However, Li added that "our study...suggests that a significantly shorter exposure may confer an increased risk."
In the trial, the researchers examined the histories of 1044 postmenopausal women with breast cancer and 469 postmenopausal women without the disease. The results showed that those who took combined HRT for as few as three years were about three times more likely to develop lobular breast tumours compared with those who did not take combined HRT.
Experts have indicated that the incidence of lobular cancer is increasing, and Li noted that "our research suggests that the use of postmenopausal HRT, specifically combined preparations, may be contributing to this
European regulators approve GlaxoSmithKline's Avamys

The European Commission granted marketing authorisation to GlaxoSmithKline’s allergic rhinitis drug, Avamys, the drugmaker announced Tuesday. The treatment is the first intranasal corticosteroid to show "consistently significant improvements" in both nose and eye allergy symptoms, the drugmaker noted.

In the EU, the once-daily nasal spray is indicated for use in adults, adolescents and children aged six to 11 years. The drug was approved by the FDA in April 2007 and is marketed as Veramyst in the US

UK Government seeks 10% drugs price cut – FT report

Suggestions that the UK government is looking to push for a 10% cut in the prices of prescription medicines on the National Health Service have raised eyebrows within the pharmaceutical industry. The Financial Times has this morning reported that Alan Johnson, the UK’s health minister, told the newspaper he plans to generate substantial savings in the £11 billion annual drugs budget during talks with industry representatives concerning the Pharmaceutical Price Regulation Scheme.This 10% figure will come as a shock to drugmakers especially as they signed a five-year deal in 2004 offering price cuts of around 7% in return for increased allowances to encourage R&D of innovative products.The Department of Health surprised drugmakers in August by saying that renegotiation of the PPRS was needed, a move which came after the UK’s Office of Fair Trading published its controversial report on the PPRS, which concluded that the NHS could save up to £500 million a year. The August statement prompted a cautious response from the Association of the British Pharmaceutical Industry which said it recognised the Government’s need to gain best value for money from all aspects of NHS services, but pointed out that the system already benefits “from one of the most cost-effective medicines policies in Europe, with high levels of generics prescribed”.The ABPI told PharmaTimes World News that it is weighing up the comments of Mr Johnson and may make a statement later today.

Tysabri doing well after relaunch

Ireland’s Elan Corp and its US partner Biogen Idec have released more favourable sales and safety data on their multiple sclerosis drug Tysabri. The firms said that as of late December, more than 21,000 patients were on Tysabri (natalizumab) and to date, the safety data “continue to support a favourable benefit-risk profile”. Specifically, in the USA, approximately 12,900 patients were on the drug on a commercial basis and 2,500 physicians have prescribed the therapy. Most interestingly, Elan and Biogen added that there have been no cases of progressive multifocal leukoencephalopathy, a rare brain disease, since the re-launch of Tysabri in July 2006. The drug was pulled off the market on safety concerns in February 2005, and its reintroduction came with restrictions to monitor patients for symptoms of PML. Tysabri is key to the fortunes of both firms (but especially Elan) and a joint meeting of the US Food and Drug Administration’s Gastrointestinal Drugs Drug Safety and Risk Management Advisory Committee voted 12 to three back in August to support the treatment in Crohn’s disease. However, European regulators have looked less favourably on the Crohn’s indication and adopted a negative opinion on the marketing authorisation filing in November.

New DPP4 inhibitor on the way

Takeda Pharmaceutical Co has filed its new diabetes treatment alogliptin with US regulators in a bid to reduce its reliance on Actos and start making up ground on Merck & Co’s dipeptidyl peptidase-4 inhibitor Januvia. The Japanese drugmaker has submitted a New Drug Application to the US Food and Drug Administration for SYR-322 (alogliptin), a DPP-4 inhibitor for the once-daily treatment of type 2 diabetes. DPP-4 inhibitors are a new class of oral agents that target the incretin system and it is thought that they reduce glucose more effectively without producing the side effects of present treatments. The NDA submission was supported by six Phase III trials involving over 2,000 patients in 220 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other medications including sulfonylureas, insulin metformin and thiazolidinediones,such as Takeda’s big-earning Actos (pioglitazone). In the studies, alogliptin was associated with statistically significant reductions in haemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. It was generally well-tolerated and weight neutral and there was no increase in hypoglycaemia compared to placebo. The Osaka-based firm’s president Yasuchika Hasegawa said that the NDA submission is a significant milestone for Takeda “as it has the potential to position us as one of the global leaders in diabetes treatment". He added that the company’s continued growth, “now and in the future, will be based on our ability to focus and have success in this therapeutic area”. If approved, a launch for alogliptin could take place in early 2009, and analysts believe it could bring in $2 billion a year. However it will have a lot of ground to make up on Merck’s Januvia (sitagliptin) which has already been available in the USA since October 2006, while Novartis will be hoping the FDA finally look favourably on its DPP-4 inhibitor Galvus (vildagliptin) before Takeda’s product hits the market. Moving into this new area of diabetes treatment is also important for Takeda given that Actos will be hit by patent expiries in the USA in 2011. The drug, despite receiving stronger label warnings recently, brought in around $2.86 billion in the last fiscal year, more than 25% of the firm’s total revenues. TAK-390MR also filed Separately, TAP Pharmaceutical Products, Takeda's US joint venture with Abbott Laboratories, said it has submitted an NDA to the FDA for TAK-390MR, a proton pump inhibitor to treat diseases caused by stomach acid, including reflux. "This compound and its novel delivery system is a promising next step in the management of erosive and non-erosive esophagitis," said Nancy Joseph Ridge, vice president of R&D at TAP.