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Early-stage collaboration with biotech firms requires comparatively small amount of money from pharma companies for enhanced access to 'drugs of the future'. Lack of funding has left many of the new technologies in early and middle stages of development from progressing to the next level. The licensing/drug development deals will help fill this funding gap.

Bristol-Myers, which was the king of oncology for decades, seems determined to regain its lost crown. The week witnessed Bristol Myers signing a deal with biotech firm Exelixis to develop cancer drugs and Danish biotech Genmab inking a $2.1 billion deal with Glaxo.

Perrigo, which has about 65% market share in the business of making store-branded Over-The-Counter products, had more than one interesting development to report this week. It's not without reason that more and more companies are focusing on Alzheimer's disease drugs. An ageing population and improved diagnosis rates are expected to boost Alzheimer's disease therapeutics market.

Australian biotech company Prana, which is focused mainly in developing compounds to treat neurodegenerative disorders commenced dosing in its Alzheimer's disease study this week. Speedel's halting of its SPP301 trial for diabetic nephropathy, sent the company's stock down 20% immediately following the news, which later recovered a few points on Tuesday. Diabetic nephropathy is a multibillion dollar market with high unmet medical needs.

According to the American Diabetes Association, 20 million people in the United States have diabetes, 90-95% of who have type 2 diabetes. About 20-30% of patients with type 1 or type 2 diabetes develop nephropathy. Though no final date has been set for the resumption of the trial, it is expected that the trial will resume by the end of the third quarter or beginning of fourth quarter 2007.

AstraZeneca seems to be passing through a difficult patch of late and European Patent Office's decision related to Nexium only added to the drugmaker's woes. In October, the company halted the development of its stroke drug NXY-059 after the drug failed to demonstrate a statistically significant reduction of stroke-related disability in patients, in a Phase III trial. Recently, the company dropped an intravenous formulation of AZD7009 for the treatment of atrial fibrillation after disappointing Phase III results.

Atrial fibrillation is a condition of rapid and irregular heartbeat. Few other newsmakers of the week were MedImmune, GenVec, Theratechnologies, Basilea Pharmaceutica, Lupin, VaxGen, Johnson Johnson, Amylin Pharmaceuticals, and Eli Lilly. Monday, Exelixis Inc.

( | | | ) and Bristol-Myers Squibb Co. ( | | | ) inked a $120 million deal to discover, develop and commercialize cancer treatments. Pursuant to the terms of the agreement, which will become effective upon antitrust clearance, Bristol-Myers Squibb will make an upfront payment of $60 million in cash to Exelixis.

In return, Bristol-Myers will gain the right to use Exelixis' drug discovery technology. In addition, Exelixis will be fully responsible for the identification and pre-clinical development of small-molecule drug candidates. Bristol-Myers, which will have the right to select three drug candidates, will pay Exelixis $20 million for each drug candidate.

The companies plan to equally share development costs, commercial profits and co-promotion responsibilities in the United States. Exelixis will also receive royalties on product sales outside of the United States. Once an industry leader in oncology drugs, Bristol-Myers is turning no stone unturned to regain its lost stature after key patents on cancer drugs like Taxol expired.

The sales of Taxol slumped 22% to $137 million in the third quarter ended September 30, 2006 from $175 million in the same period last year, due to increased generic competition in Europe and generic entry in Japan during the third quarter. With cancers now being considered treatable chronic diseases, as more and more cancer treatments are beginning to show promise, the market for oncology drugs is expected to grow at a rate of 20%. According to IMS Health, the drug market as a whole is projected to grow by just 5% - 6% in 2007 and the anti-cholesterol market by 1% - 2%.

In the richest biotech deal ever, Danish biotech Genmab A/S on Tuesday inked a US$2.1 billion deal with Glaxosmithkline plc ( | | | ) for global commercialization of a leukemia treatment - HuMax-CD20. HuMax-CD20 is a fully human antibody, currently in Phase 3 clinical trials for treating chronic lymphocytic leukemia and non-Hodgkin's lymphoma.

The investigational drug is also under a phase II trial for rheumatoid arthritis. Pursuant to the terms of the agreement, Genmab will receive a license fee of approximately $102 million, and receive milestone payments of $1.6 billion.

The agreement also provides for Glaxo to invest about $357 million to purchase 4.47 million ordinary shares of Genmab. Glaxo, which will receive an exclusive worldwide license to HuMax-CD20, will be solely responsible for the manufacturing and commercialization of the antibody.

In addition Glaxo will get an exclusive option to a CD20 UniBody to be developed in collaboration with Genmab. The drug, if approved could capture the market share of Rituxan, produced by Genentech and Biogen IDEC, which had annual sales of $1.83 billion last year.

Following the news, shares of Glaxosmithkline fell 0.9% to close at 1,332 pence on the London Stock Exchange. Wednesday, MedImmune Inc.

( | | | ) the maker of the nasal flu vaccine FluMist, licensed its proprietary reverse genetics intellectual property to Australian biotech firm CSL Ltd. to support the development of new human seasonal and pandemic influenza vaccines. Financial terms of the deal were not disclosed.

Reverse genetics technology is an important breakthrough for the manufacturing of all influenza vaccines as it does not require vaccine manufacturers to work directly with the infectious pandemic strain, such as H5N1, rather only segments of the viral DNA. The reverse genetics technology of MedImmune will be used by CSL to develop both seasonal and pandemic flu vaccines. MedImmune will receive an upfront payment and has the potential to receive royalties on any vaccine stockpiles or other product sales using the reverse genetics technology.

Earlier this year, the National Institutes of Health began enrolling participants in a Phase 1 study of an intranasal H5N1 influenza vaccine candidate based on MedImmune's live, attenuated vaccine technology, using reverse genetics technology. MedImmune's Flumist, which had a disappointing year on its launch in 2003, appears to be on the road to recovery. In the third quarter ended September 30, 2006, sales of Flumist rose 52% from last year, although it accounted for only $16 million in total revenue.

The company's third quarter loss narrowed to $55.8 million, on revenues of $177.2 million.

In the year-ago quarter, the company posted a loss of $64.1 million, on revenues of $153.6 million.

The sales of FluMist are expected to rise, once the vaccine is approved for use in younger children and older adults. Currently the vaccine is approved only for use in healthy patients between 5 and 49 years old. The biotech giant, which is yet to get regulatory approval for a new refrigerator-stable version of Flumist, hopes to launch the new vaccine next year.

Earlier this month, the company said that it anticipates reporting revenues of $1.3 billion for 2006, $1.5 billion next year and $2 billion by 2009.

On December 14, David Katz, one of the major shareholders of MedImmune, sent a letter to the company to put itself up for sale to increase shareholder value. The company's stock is now down 11%, compared to last year. Analysts have long speculated that MedImmune may become a takeover target for potential buyers like Merck and Johnson Johnson, looking to shore up its future.

However, the company's board continues to "unanimously believe" that MedImmune should remain independent. Tuesday, shares of biotech company GenVec Inc. ( | | | ) surged 30% to $2.

46 after initial interim efficacy analysis of its ongoing Phase II/III trial with TNFerade, demonstrated a 42.5% absolute increase in overall survival of patients with locally advanced pancreatic cancer. TNFerade is a DNA carrier, which contains the gene for tumor necrosis factor-alpha or TNF-alpha, an immune system protein with anti-cancer effects, for direct injection into tumors.

After administration, TNFerade stimulates the production of TNF-alpha in the tumor. The study known as PACT trial is targeted to enroll 330 patients with locally advanced pancreatic cancer. The first 51 patients enrolled in the trial were randomized to receive TNFerade plus standard of care or standard of care alone.

At one year, survival was 70.5% in the TNFerade plus standard of care arm, compared to 28% in the standard of care alone arm. Standard of care refers to a diagnostic and treatment process that a clinician usually follows for a certain type of patient, illness, or clinical circumstance.

The TNFerade plus standard of care arm, which signed up 33 patients, reported 5 deaths whereas there were 7 deaths in the standard of care alone arm, which had 18 patients. Tuesday, Australian company Prana Biotechnology Ltd. ( | | | ) commenced dosing in its Phase IIa clinical trial of PBT2 in patients with early Alzheimer's disease.

The Phase IIa trial, which is conducted in seven centers throughout Sweden, will test the safety and tolerability of PBT2, Prana's proprietary lead compound. In preclinical studies with mice, PBT2 reduced the molecule level that triggers Alzheimer's disease by 60% within 24 hours of oral administration. Out of the 80 Alzheimer's disease patients enrolled in the trial, 20 patients will receive a 50mg dose while 30 patients will receive a 250mg dose of PBT2.

The remaining 30 patients will receive the placebo. The trial duration is for a period of three months. The primary endpoint of the study will be the safety and tolerability of PBT2.

Results are expected to be announced in the fourth quarter of 2007. Prana's pipeline has over 300 proprietary investigational compounds to treat a variety of neurodegenerative disorders like Alzheimer's disease. The Alzheimer's disease drugs market has become increasingly competitive as potentially disease modifying drugs compete for approval.

The current drugs for Alzheimer's disease only provide temporary partial symptomatic relief while disease modification and prevention remain the major unmet needs. Tuesday, Theratechnologies Inc. ( | | | ) reported positive results from a phase 3 study of its lead compound, TH9507, in patients with HIV-associated lipodystrophy, a serious medical condition common in HIV patients.

Following the news, the company's stock jumped 75% to C$4.80 on the Toronto Stock Exchange. In HIV-patients, there will be notable abdominal fat accumulation as well as lipid and carbohydrate disorders like high cholesterol and blood sugar that encourage cardiovascular disease and type 2 diabetes.

In the first, placebo-controlled Phase 3 trial, the 412 patients enrolled in the trial were administered a daily dose of 2 milligrams of TH9507 for a period of 26 weeks. The primary endpoint set for the study was a reduction of visceral adipose tissue, or VAT, which is a risk factor for cardiovascular disease and type 2 diabetes. At the end of the study period, patients treated with TH9507 achieved an average reduction of 15% in visceral adipose tissue, compared to an average increase of 5% in the placebo group.

TH9507 was also found to be well tolerated in patients. Theratechnologies noted that a second Phase 3 trial to confirm the results of the first trial is set to get underway in North America and Europe during the first quarter of 2007. The company received a Special Protocol Assessment for the second trial from the FDA in August 2006.

Based on the latest estimate of 250,000 HIV patients who suffer from fat buildup or HIV-associated lipodystrophy, the proposed drug is expected to have an annual market potential of US$350 - US$850million. Serostim, which is yet to receive FDA approval, manufactured by Serono SA of Switzerland is now used by doctors to treat HIV-associated lipodystrophy. Serostim is anticipated to get FDA approval next year.

Swiss company Speedel Holdings AG (SPDHF.PK) halted a phase III trial of its drug SPP301 for diabetic nephropathy (kidney disease) on safety concerns. The 4-year pivotal Phase III study of SPP301 was initiated in July 2005, and its costs were estimated to be about $76.

9 million. Speedel was looking at a market potential of $3 - $4 billion for its investigational drug SPP301. Following the news, the shares tumbled 14.

4% to 165.30 Swiss francs. Speedel has exclusive worldwide development and commercialization rights to SPP301 under a licensing agreement with Roche.

Speedel halted the trial after finding a significant imbalance in fluid retention in patients enrolled in the study. Fluid retention, which is common in patients who have severe diabetic kidney disease can also cause high blood pressure and may eventually contribute to heart disease. However the company remains optimistic about the potential use of SPP301, which will be tested for new indications.

Speedel's U.S. rival, Keryx Biopharmaceuticals Inc.

is working on a similar drug to combat diabetic nephropathy. The investigational drug Sulonex is expected to be approved by the FDA in 2008, according to Merrill Lunch analyst Tom McGahren. Tuesday, Swiss company Basilea Pharmaceutica Ltd.

, initiated two primary-treatment phase III clinical trials with isavuconazole for the treatment of fungal infections - candidemia and invasive aspergillosis. Isavuconazole was granted fast track status by the FDA due to its potential to satisfy a high medical need. The global trial program of isavuconazole targets two significant patient groups namely hematological cancer patients and patients in the intensive care unit setting.

The first phase III study is designed to evaluate the safety and efficacy of isavuconazole versus Pfizer's voriconazole for the primary treatment of invasive fungal disease. The second phase III study compares isavuconazole with a candin-based treatment in curing candidemia and other invasive candida or fungal infections. Isavuconazole is the third of Basilea's development compounds to reach phase III pivotal trials.

The company's two other investigational drugs currently in phase III are ceftobiprole, indicated for the treatment of serious bacterial infections in hospitalized patients and alitretinoin, a topical treatment to be developed specifically for Chronic Hand Dermatitis. Lupin Pharmaceuticals Inc, the wholly owned U.S.

subsidiary of Mumbai, India based Lupin Ltd. on Wednesday, received tentative approval from the FDA for its abbreviated new drug application for trandolapril tablets, 1mg, 2mg and 4mg. Final approval for Lupin's trandolapril, the generic equivalent of Abbott's Mavik tablets, indicated for hypertension is expected, upon its patent protection expiry on June 12, 2007.

According to IMS sales data, the brand product Mavik had annual sales of about $53 million for the twelve months ended July 2006. The potential market for hypertension drugs is expected to expand drastically as another 59 million people are on the borderline of developing hypertension in addition to the 65 million Americans who are said to suffer from hypertension, according to the American Society of Hypertension. Last year the sales of the drugs used to treat hypertension totaled $17 billion.

Keeping Up the Good Work - Perrigo Gets FDA Approval For Ciclopirox, Simvastatin Generic and store-brand drugs maker The Perrigo Co. ( | | | ) on Tuesday announced that its antifungal medication Ciclopirox Topical Suspension USP. 0.

77% has been granted approval by the FDA. Perrigo's Ciclopirox Topical Suspension is the AB-rated equivalent to Medicis Pharma's Loprox Topical Suspension, 0.77%, indicated for the topical treatment of common skin infections such as athlete's foot, jock itch, and ringworm.

According to Wolters Kluwer data, annual sales of Loprox Topical Suspension for the last 12 months were about $42 million. On Thursday, Perrigo, the nation's largest manufacturer of store-brand, over-the-counter pharmaceuticals and vitamins, received FDA approval to market Simvastatin Tablets, USP of dosages 5 mg, 10 mg, 20 mg, 40 mg and 80 mg. Simvastatin is the generic equivalent of Merck's Zocor indicated to reduce the risk of death in patients with coronary heart disease and high cholesterol.

Shipments of the product, which is manufactured by its partner Bentley Pharmaceuticals is expected to begin immediately. Zocor lost its U.S.

patent protection on June 23, this year. According to Wolters Klewer data, annual sales of Merck's blockbuster Zocor, for the last 12 months ended September, 2006 were approximately $5 billion. In yet another news related to Perrigo, the company's partner Dexcel Pharma Technologies was issued an approvable letter for its New Drug Application for over-the-counter omeprazole 20mg delayed-release tablets indicated for the treatment of heartburn.

On approval of over- the-counter omeprazole by the FDA, Perrigo will be Dexcel Pharma's exclusive marketer and distributor for the product in the U.S. However, the approval hinges on the verdict of the patent infringement suit filed by AstraZeneca against Dexcel related to Prilosec OTC.

AstraZeneca's Prilosec is also a 20 mg omeprazole magnesium tablet that is on the OTC market approved by the FDA for the treatment of heartburn. For the twelve months ended November 26, 2006, Prilosec OTC had annual sales of about $600 million. Last month, Perrigo recalled 11 million bottles of acetomenophine because of small metal scraps inside, costing the company nearly $2.

9 million. Acetominophen is a common over the counter pain reliever. For the first quarter ended September 30, 2006, the company earned $17.

5 million or $0.19 a share, on revenues of $340.86 million.

This compared to $12.9 million or $0.14 a share, on revenues of $319.

7 million in the year-ago period. While announcing its first quarter results on October 31, 2006 Perrigo stated that it anticipates earnings in the range of 86 - 91 cents per share for fiscal year ending June 2007. Wall Street analysts have earnings per share consensus estimate of 88 cents a share.

It needs to be seen whether Perrigo will revise its earnings outlook following the FDA approval for its new products. Monday, VaxGen, Inc (VXGN.PK) announced that the FDA's Center for Biologics Evaluation and Research is maintaining its clinical hold on the company's second Phase II trial for its investigational anthrax vaccine due to continued concerns about the product's stability.

Under the terms of a contract inked with VaxGen, the Department of Health and Human Services had agreed to purchase 75 million doses of the company's recombinant anthrax vaccine, rPA102. According to the contract, December 18 was imposed as the deadline for the company to initiate its next clinical trial for the vaccine candidate. Following the FDA's decision, the U.

S. government cancelled the $877.5 million contract awarded to VaxGen to produce an anthrax vaccine.

The contract awarded two years ago is part of the government's $5.6 billion Project BioShield program to safeguard against terrorist attacks. Wednesday, Johnson Johnson's ( | | | ) Invega, a new antipsychotic for the treatment of schizophrenia was approved by the FDA, making it the first treatment to be approved for this indication since 2003.

Invega is an extended release version of Johnson Johnson's blockbuster schizophrenia drug, Risperdal, which is expected to go off patent in 2008. Last year, Risperdal ringed in sales of $2.3 billion.

However, Invega's label will also contain an unexpected warning that it can cause side effects such as heart problems. Analysts believe that the drug's warning is less severe than Pfizer's Geodon, which is also an antipsychotic drug. Antipsychotic drugs now account for over $10 billion in U.

S. sales. According to JP Morgan analyst Michael Weinstein, Invega is expected to garner sales of $488 million in 2007, ballooning to $1.

78 billion by 2009. Invega will be available in the U.S.

in January 2007. Friday, Amylin Pharmaceuticals, Inc. ( | | | ) and Eli Lilly and Co.

( | | | ) announced that the FDA approved Byetta injection as an add-on therapy to improve blood sugar control in people with type 2 diabetes who have not achieved adequate control on a thiazolidinedione. The medication class of thiazolidinedione was introduced in the late 1990's as an adjunctive therapy for type-2 diabetes. Byetta also known as Exenatide, indicated for the treatment of type 2 diabetes was launched in the U.

S. in June 2005. In the United States, Lilly co-markets the drug with Amylin, sharing the revenue equally.

Byetta was approved by the European Commission only last month. In Europe, the entire sales will be handled by Lilly and Amylin will be paid a royalty. Byetta lowers blood glucose significantly in people with type 2 diabetes besides reducing the patients' weight by 5 - 60 pounds, whereas treatment with insulin is often associated with weight gain.

Net sales of Byetta were over $242 million in its first year on the market. Jim Reddoch, an analyst with Friedman Billings Ramsey Co. in his recent research note said that he expects Byetta to garner at least $2 billion in annual sales by 2011.

The current leading market players in the treatment of type-2 diabetes are Takeda, which produces Actos, and GlaxoSmithKline, the maker of Avandia. Merck's Januvia won FDA approval for the treatment of type- 2 diabetes last month and Novartis' Galvus also meant for the treatment of type- 2 diabetes, is awaiting FDA approval. Tuesday, shares of AstraZeneca plc ( | | | ) declined 3.

5% to $53.66 following the European Patent Office withdrawal of patent covering the U.K.

drug maker's blockbuster drug Nexium, prescribed for heartburn. The patent for the chemical composition of the drug was scheduled to expire in 2014. Nexium has other patents and data exclusivity through 2010 in major European markets.

Nexium's patent was challenged by German generic-drug maker Ratiopharm GmbH. The details of the European Patent Office's decision, which cannot be appealed, will be revealed next year. Meanwhile a patent hearing is scheduled on March 7, 2007.

In March this year, AstraZeneca sued Teva and its Ivax Corp unit for infringing its patents on Nexium. The company also sued Ranbaxy Labs of India, which is planning to sell a generic version of Nexium. The cases are yet to be taken up for hearing and it needs to be seen whether the European Patent Office decision will influence the ruling of the U.

S. Courts. According to IMSHealth, Nexium is the world's third most-prescribed branded medication for ulcer.

Last year, the drug garnered in global sales of $4.6 billion, with Europe accounting for about $1.1 billion.

AstraZeneca launched Nexium in 2001 - a year before the company's top seller, Prilosec also prescribed for ulcers, lost patent protection in 2002. To help ensure safe use of over-the-counter products, the FDA on December 19, proposed to amend the labeling regulations on products such as aspirin, ibuprofen, naproxen and ketoprofen that are used to treat pain, fever, headaches, and muscle aches. The amended labels include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor.