The US biotech firm Unigene Laboratories has entered an agreement with the UK drug maker GSK to provide development services and clinical supply in preparation of the potential Phase III trial of oral parathyroid hormone (PTH) for the treatment of Osteoporosis in postmenopausal women.

The Boonton, NJ-based company will be entitled to receive up to approximately $2.2 million payments in milestone from GSK for certain development and manufacturing activities, which are related to the active pharmaceutical ingredient and finished drug product for an oral formulation of a recombinantly produced investigational PTH analog.

The drug candidate is in the development process for the treatment of osteoporosis in postmenopausal women by Unigene and GSK, which potentially may decide to move the clinical study the therapy into a Phase III program.

Unigene is collaborating with GSK for the development of oral PTH as part of an exclusive worldwide licensing agreement. The company said that the investigational oral PTH is currently in Phase II study with top-line results expected before the year end. Unigene received $4 million upfront payment from GSK in December to cover costs associated with the Phase II study, and also received an additional $4 million payment in May upon completion of Phase II patient enrollment. The company is also eligible to receive further payments of up to approximately $140 million based on the achievement of regulatory and commercialization milestones and tiered double-digit royalties in the low-to-mid teens on global sales

Unigene president and CEO Ashleigh Palmer they are highly focused on advancing their oral PTH that they believe has the potential to address an important medical need.

“We have made tremendous progress with our Phase 2 program since the beginning of the year and are thrilled to be working closely with GSK on the most advanced oral PTH in development”,  said Ashleigh Palmer, “We believe the signing of this agreement reflects our validated, proprietary oral peptide delivery technology and state-of-the-art recombinant manufacturing capabilities and our growing leadership in the peptide sector.”

Scientists from Imperial College London in UK  are planning a clinical study to test a stem cell treatment in upto 150 patients with multiple sclerosis across Europe.

The trial, led by Dr Paolo Muraro from Imperial College London, is reportedly set to begin later this year. People involved in the study are saying that it’s the first trial of its kind to test the potential of stem cells to treat the neurological disorder.

The plan is to harvest stem cells from the bone marrow of participants, grow them in a lab, and then implant them in multiple sclerosis patients. Researchers are hoping that the cells might even reverse some of the nerve damage caused by the chronic condition, which impacts about 100,000 people in the U.K. and 3 million patients globally, according to a BBC report.

“Stem cells have great potential to treat MS. The effect we are looking to achieve will mean fewer relapses, stop the progression of neurological dysfunction and even reduce disability,” said Dr Paolo Muraro.

It’s likely to be a few years before the trial yields any results, but there are a bevy of biotechs that might be interested in this approach to treating MS if it yields good safety and efficacy data. Existing drugs against MS are intended to slow the progression of the debilitating disease, but companies like Biogen Idec ($BIIB), the worlds largest maker of multiple sclerosis drugs, have their eyes on potential ways to heal some of the nerve damage caused by the illness.

The research has been part-funded by the UK’s MS Society, which is concerned about the availability of unproven stem cell treatments.

”Stem cells hold tremendous potential as a future treatment option for people with MS,” Simon Gillespie, chief of the MS Society, which is a partial backer of the study, told The Telegraph. “We are delighted to be funding this world-leading piece of research which shows the power of an international research collaboration and joint working between charities.”

Scientists from a French biotech company have developed a novel hepatitis C vaccine that may offer the first effective way to prevent an infection that can cause chronic liver disease and cancer.

The  French biotech Epixis holds the rights to an experimental hepatitis C vaccine which scientists say was able to combat a variety of hepatitis C viruses in animals by spawning neutralizing antibodes–a new approach in the hep C vaccine field. The latest experimental shot has been tested successfully on mice and monkeys, but not humans, and has been shown to activate a broad response from immune system proteins called neutralizing antibodies.

Various biotechs in the field have been using a T-cell approach to guard against hepatitis C. But Epixis and the researchers testing the vaccine believe they have a superior technology.

“For a preventative vaccine, neutralizing antibodies are absolutely essential, and for a therapeutic product they would also be a big advantage,” researcher David Klatzmann told Reuters.

Charlotte Dalba, the CEO of Epixis, which is reportedly being bought by an U.S. drug developer, says that the company hopes to launch human trials next year, provided the money is available. If they’re successful, Epixis–or whichever developer is acquiring it–will be advancing a rival vaccine to programs being pushed by France’s Transgene and Austria’s Intercell, which has been plagued with clinical setbacks recently.

Reuters noted that the demand for a hepatitis C vaccine would largely be in the developing world–not a market that most big drug developers find commercially appealing. But Dendreon and Merck have both produced new treatments which are expected to earn billions. Roughly 130 million to 170 million people suffer from chronic hepatitis C. – here’s the story from Reuters

Cerenis Therapeutics,  a French biotech company, has pushed its novel therapy for increasing HDL cholesterol levels into a large scale mid-stage trial in patients with acute coronary syndrome (ACS).

Cerenis said the double-blind, randomized, placebo-controlled Phase II clinical study for the experiment drug CER-001, involving more than 500 patients from the United States, Canada and Europe, was aimed to investigate the drug’s safety and efficacy to remove plaque from clogged arteries.

CER-001  mimics the structure and function of natural HDL,  which is believed to be protective against atheroscleros by removing excess levels of artery-clogging low density lipoprotein (LDL) plaque from the wall of blood vessel. As a complex of recombinant human ApoA-I,  the drug will be given in the clinical trial as a series of six weekly infusions to patients who have recently suffered a heart attack.

Dr. Jean-Claude Tardif, the principal investigator of the study from the Research Centre at the Montreal Heart Institute, commented, “We are excited to be conducting the CHI-SQUARE study, which aims to show benefits of CER-001 on atherosclerotic plaque following a short course of therapy. This is the largest IVUS study conducted with a pre-beta HDL mimetic, and represents a potential new treatment paradigm to reduce the burden of atherosclerosis.”

Since its inception in 2005, Cerenis has raised 117 million euros through top tier investors. The company would take a pragmatic approach to partnerships and future financing, including a potential stock market float, according to Jean-Louis Dasseux, the CEO of Cerenis.

“There are multiple options. We believe that as soon as we have demonstrated that we could reduce plaque then there will be no problem to secure more financing, either by an IPO or doing a deal with a Big Pharma (company) or raising more (private) money,” said Jean-Louis Dasseux.

He added “The potential of HDL therapy is well recognized and CER-001, as a first in class pre-beta HDL mimetic, could have great therapeutic value to patients with ACS.”

As part of Samsung’s efforts to expand its business into the biopharmaceutical sector, the South Korea electronic company is to form a new joint venture company with Quintiles, an U.S. contract research organisation.  

Quintiles will invest $30 million (18.49 million pounds) in the joint venture, representing a ten percent stake, with the new company set to provide biopharmaceutical contract manufacturing services.

This will encompass the construction of a new facility in South Korea that will utilise an 8,000-gallon mammalian cell culture bioreactor to produce biopharmaceutical products for international distribution.

Samsung intends to continue its expansion into the sector in the coming years by commercialising biosimilar treatments by 2016.

Paul Casey, vice-president and head of Asia corporate development for Quintiles, said the deal “shows we are committed to developing non-traditional alliances in order to help our customers navigate risks and seize opportunities in the complex industry landscape and ultimately help patients”.

The Irish biotech company Elan and German drugmaker Boehringer Ingelheim have formed an alliance to develop and manufactur antibody-based therapeutics, according to the company statement. 

Elan is a neuroscience-based biotechnology company based in Dublin. The company will be responsible of leading the discovery science, pre-clinical activities, clinical development and commercialisation of therapeutic antibodies. While  Boehringer Ingelheim will perform the technical development, clinical manufacturing and all related regulatory filing support services for antibodies discovered by Elan.

“We are excited to collaborate with Boehringer Ingelheim, a highly regarded and world-class leader in biological technical development and manufacturing.,”  said Dr Johannes Roebers, Senior Vice President at Elan, “The agreement enables Elan to focus resources on discovery and the clinical progression of our science while leveraging Boehringer Ingelheim’s process development and production capabilities.”

Simon Sturge, Corporate Senior Vice President of the Biopharmaceuticals Division at Boehringer Ingelheim, said, “The combination of Elan’s successful track record in the discovery and clinical development of antibody-based therapeutics with our proven expertise in technical development and manufacturing and in particular our BI HEX® platform, will be an optimal fit. This is a first step in our new strategy engaging our technology platforms at a very early stage in product development. We look forward to working with the team at Elan.”

 Boehringer Ingelheim announced last month that it will be teaming up with Lilly to collaboratively create new therapies for diabetes.

The US pharma giant Merck is forming an alliance with Parexel, a contract-research organization,  to develop biosimilars, and hopes to have at least five of the compounds in late-stage trials by 2012.

The CRO will create a dedicated unit within the company for Merck BioVentures. The new unit will be responsible for developing new versions of existing biotech drugs, provide its clinical development services for Merck BioVenture, including access to regulatory strategy and clinical development planning services for the development of broad classes of biosimilars. 

Founded in 2008, Merck BioVentures aims at developing new biotech drugs and follow-on biologics. In 2006, Merck acquired Glycofi, a biotech company now as one of the major player of  Merck BioVentures. Glycofi’s technology uses yeast instead of mammal cells to make proteins to developing new versions of older biologics.

Michael Kamarck, president of Merck BioVentures, commented, “Through this agreement, Merck BioVentures has secured broad strategic access to PAREXEL’s proven biosimilar clinical development experience. This agreement positions Merck BioVentures for success with an industry leading partner that has the expertise and resources to conduct clinical development of our diverse portfolio of candidates to allow timely delivery of products to the marketplace.”

Biosimilars are already being sold in Europe, but U.S. regulators haven’t yet determined how to handle them. Last fall the FDA held a meeting to discuss the approval process for biosimilars. At issue is whether makers of new versions of large-molecule drugs will have to conduct their own trials to assure safety and efficacy.

Sandoz,  Novartis’ generics unit, has begun mid-stage study of a biosimilar version of Roche’s blockbuster antibody drug Rituxan/MabThera.

According to the company, the Phase II trial for the biosimilar version of Rituxan (rituximab) is focusing on the therapy of rheumatoid arthritis.

Sandoz said in a statement that  it has developed “a robust, high-yield and large-scale process for the production of biosimilar rituximab” over the last few years. To ensure biosimilarity with the reference product, “a comprehensive physico-chemical and functional analysis of the product was conducted using modern bioanalytic techniques, followed by further studies”. Data so far suggest that its version is “highly similar to the reference product, justifying initiation of clinical studies in patients”.

Jeff George, Sandoz global head,said: “This key development milestone demonstrates that Sandoz, the pioneer in biosimilar, is on track to maintain its global leadership position in the medium to long-term.

“With nearly 50% market share within the global regulated biosimilar market, and with three marketed products, Sandoz plans to continue to broaden patient access to essential high-quality biologics by consistently advancing our industry-leading development pipeline.”

Rituxan is a huge earner for Roche, and Novartis says it ranks among the top three biologics worldwide, with 2009 sales of $5.60 billion.

Other companies are working on a biosimilar of Rituxan, notably Teva Pharmaceutical Industries, while last week Spectrum Pharmaceuticals signed a pact with Viropro to develop a version of rituximab ahead of its US patent expiration in 2015.

The license agreement gives MedImmune exclusive access to a portfolio of Evotec’s research programs. In return, Evotec will get $6.6 million upfront payment and is eligible for additional deferred payments including potential clinical, regulatory, and commercial milestone payments of up to $336 million, plus royalties. The firm will also receive research funding to support in vitro and in vivo pharmacology work in collaboration with MedImmune.

 Dr Cord Dohrmann,Evotec chief scientific office, said, “Using a unique screening approach for beta cell regeneration targets, we have identified and validated novel and highly relevant biological factors,” he also added “The most advanced factor has demonstrated efficacy in animal models of beta cell regeneration in particular increasing the functional beta cell mass and thereby improving and restoring glycemic control. Together we intend to generate a pipeline of biological factors that have the potential to prevent or reverse disease progression, and confer optimal glycemic control in patients.”

MedImmune, which AstraZeneca bought in 2007 for $15.2 billion, manufactures the flu vaccine FluMist and the respiratory drug Synagis