Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

Servier and the Belgium-based biotechnology company Galapagos are embarking on a multiyear strategic alliance to develop new cancer therapies. As a result of the alliance, Galapagos could receive milestone payments of more than EUR 250 million ($332 million).

The alliance will build on a combination of novel oncology targets from both companies. Galapagos will be responsible for the discovery and development of new candidate drugs, and Servier will have the exclusive option to license each small-molecule program after Galapagos has completed preclinical development. In exercising this option, Servier will be responsible for further clinical development, registration, and commercialization. However, Galapagos will retain exclusive rights for clinical development, registration, and commercialization in the US.

“In this new alliance, Servier and Galapagos combine both their oncology targets and their capabilities in cancer drug discovery,” said Onno van de Stolpe, CEO of Galapagos, in a 

. “Similar to our osteoarthritis alliance with Servier, Galapagos retains the US rights, which represents a large potential, considering the unmet medical need in cancer.”

Galapagos will receive research access payments of EUR 2 million ($2.65 million) from Servier and will also be eligible for discovery, development, regulatory, and other milestone payments that could reach EUR 260 million ($345 million), plus royalties, upon commercialization of products by Servier.

“Based on the progress made already in our osteoarthritis collaboration with Galapagos, we are convinced of Galapagos’s ability to deliver new cancer drugs based on novel targets. This alliance complements our very innovative cancer pipeline,” said Emmanuel Canet, Head of R&D at Servier, in the press statement.

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Servier and Galapagos Form Cancer Collaboration

The latest meeting of EMA’s Committee for Medicinal Products for Human Use (CHMP) has concluded with more than 15 positive opinions for new and generic drugs. Among other important announcements, the agency released a range of concept papers and guidelines for consultation and announced a safety review of orlistat-containing medicines.

, which took place Sept. 19-22, 2011, CHMP adopted several concept papers from various working groups. Each of the following noteworthy adopted papers was opened for a 3-month public consultation period: the Biologics Working Party’s concept paper for a guideline on the quality of porcine trypsin used in the manufacture of human biological medicinal products; the Vaccine Working Party’s concept paper on revising guidelines for influenza guidelines; and the Biosimilar Medicinal Product Working Party’s paper on revising the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance. CHMP also adopted three new documents, two of which focused on guidelines for herbal medicines and one on revising an EMA clinical investigation guidance.

CHMP also offered several positive approvals for new drugs. One such 

 was for a novel antibiotic agent, which represents the first in a new class to treat infections with 

, a leading cause of disease in hospitals. Dificlir (fidaxomicin), developed by Optimer Pharmaceuticals and Astellas Pharma Europe, is a macrocyclic antibiotic with a new mode of treatment that reduces the chances of its activity being affected by resistance to other antibiotics. According to the EMA statement, the approval is a “major step forward by providing a new medicine to tackle the growing levels of resistance to available antibiotics.”

Positive opinions were also given for Novartis’s Rasitrio, for the treatment of essential hypertension, and Bristol-Myers Squibb and AstraZeneca EEIG’s Komboglyze, for the treatment of Type II diabetes mellitus. Gilead Sciences International and Janssen-Cilag International also received approval for their medicines (Eviplera and Edurant, respectively) aimed at treating HIV-1 infection.Several generic drugs were approved as well, including pioglitazone, used to treat Type II diabetes mellitus, and desloratadine, used to treat alletgic rhinitis and urticaria.

 of orlistat-containing anti-obesity medicines to determine whether rare cases of hepatic injury will have any impact on the benefit-risk profile and conditions of use. The review will include the centrally authorized prescription-only medicine Xenical and the centrally authorized over-the-counter-medicine Alli, as well several other medicines containing orlistat that have either already or are in the process of being authorized at national level.

The latest meeting of the EMA's Committee for Medicinal Products for Human Use has concluded with more than 15 positive opinions for new and generic drugs and the adoption of key concept papers.

EMA Committee Offers Positive Opinion on New Drugs, Moves Forward with Key Concept Papers

GlaxoSmithKline (GSK) is looking to racecar technology as it seeks to improve its manufacturing, R&D, and consumer-healthcare areas. The company has formed a long-term partnership with the UK-based McLaren Group, which is best known for its expertise in the Formula 1 motor sport.

Under the terms of the agreement, McLaren will share its capabilities in engineering, technology, analytics, and strategy modeling to help improve performance at GSK’s global businesses. The partnership will initially last until 2016.

Initially, the partnership will examine GSK’s manufacturing, R&D, and consumer healthcare segments. The companies are evaluating a strategic program to apply McLaren’s engineering and technical expertise to GSK’s production lines to reduce breakdowns and improve costs and customer service. McLaren’s technology will also be used to improve clinical research processes by accelerating trial design and enabling real-time patient monitoring and treatment adjustment. Finally, GSK will work with McLaren’s Formula 1 Mission Control unit, which analyzes the team’s performance and directs decision making during a Grand Prix, to create a similar facility at GSK. This facility could quicken responses to consumer activity and customer needs and inform decision making about inventory management, pricing, and retailer stocking.

“I am delighted to announce this partnership with McLaren, which brings together two British companies whose continued success hinges on the ability to innovate and rapidly respond to change and competitor activity,” said Andrew Witty, CEO of GSK, in a 

. “McLaren has an unparalleled reputation for innovation built on rigorous analytics and fast decision making.”

“This all-new collaboration between McLaren Group and GSK—McLaren’s first ever such association with a major pharmaceutical corporation—represents a strategic partnership that engages two great British companies at a variety of levels across a number of disciplines in a multifaceted and groundbreaking way,” said Ron Dennis, executive chairman at McLaren Group and McLaren Automotive, in the statement. “Specifically, our intention is that GSK will harness McLaren’s world-beating Formula 1-bred technology, processes and operational dynamism, in order to enhance its performance across a wide variety of its divisions in a way that none of its competitors can match. In today’s challenging economic conditions, we firmly believe that innovative associations such as ours will play an increasingly significant role in ensuring that the UK remains globally competitive in the field of scientific innovation.”

GSK to Harness Formula 1 Technology

The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission’s 2010 amended pharmacovigilance legislation.

The concept paper details several topics including:

the quality system for the performance of pharmacovigilance activities

the use of internationally agreed terminology, formats, and standards

monitoring data in the EudraVigilance database

the electronic transmission of suspected adverse reactions

electronic periodic safety update reports and risk-management plans

, these measures will supplement essential aspects of the new pharmacovigilance system with the more technical details that must be observed by marketing authorization holders, national competent authorities, and EMA in the daily practice of applying the new legislation. “It is therefore important that they are fit for purpose and strike the necessary balance between the fundamental objective of the current legislative framework for medicinal products, i.e. to safeguard public health, and general internal market requirements,” explains the concept paper. 

The new legislation was formalized last year (Directive 2010/84/EU amending Directive 2001/83/EC, and Regulation (EU) No. 1235/2010 amending Regulation (EC) No 726/2004). According to an implementation plan, most of the provisions will come into force by the end of July 2012.

“This new public health legislation is far reaching in scope and in depth and goes far beyond any narrow concept of pharmacovigilance,” said the EMA in the implementations plan. “The legislation strengthens safety monitoring, [rationalizes] reporting and increases the use of studies including pharmacoepidemiology, makes clear roles and responsibilities, sets out decision-making, increases participation, reinforces transparency and strengthens the action that can be taken to protect and promote public health.”

The paper describes the scope and content of the implementing measures and will be available for consultation until Nov. 7, 2011. The Commission is seeking the views of all stakeholders, and details on how to participate are available on the EMA website.

The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission's 2010 amended pharmacovigilance legislation.

European Commission Consults on Pharmacovigilance

Pfizer has completed its cash tender offer for the biopharmaceutical company Icagen (Durham, North Carolina) after extending its initial deadline twice. The tender offer of $6 per share was originally scheduled to expire on Aug. 31, 2011, but had to be extended on both 

 after insufficient shares were tendered. 

When the first offer expired, Pfizer was just short of the shares required to finalize the deal when only 4,044,035 of the necessary 4,151,466 shares were tendered, despite Icagen 

 its recommendations for shareholders to accept the offer on two occasions. After an extension until the end of Thursday, Sept. 1, Pfizer was still 39,799 shares short, but a second extension until 6:00 pm on Friday, Sept. 2 proved more successful. Approximately 4,617,045 shares have now been tendered, giving Pfizer a 54% 

Pfizer and Icagen announced their intentions to merge in 

. According to a letter to Icagen shareholders, the $6 offer represented a premium of 150% to the $2.40 closing price of Icagen stock on June 24, 2011. The offer was unanimously recommended by Icagen’s board of directors and the aggregate transaction, including the shares already owned by Pfizer at the time, was valued at approximately $56 million. 

 from investment firms Merlin Nexus and New Leaf Venture Partners, however, the offer undervalues the company. In particular, the investors are disappointed that the acquisition was announced ahead of near-term milestones involving pain programs partnered with Pfizer. 

In a letter written to Icagen’s board of directors, the firms estimate the “value of Icagen's pain programs alone at as much as $100–$165 million or $11–$19 a share.” The release also adds: “Pfizer advanced the first of Icagen's proprietary compounds (PF-05089771) into a Phase I single-dose escalation study in December 2010, and this trial was expected to have been completed in March 2011. According to the letter, ‘trial data are open to Pfizer as they are required to monitor safety. These data provide Pfizer with an unfair advantage not afforded to all investors to determine the value of this program’.”

Pfizer has completed its cash tender offer for the biopharm company Icagen after extending its initial deadline.

Pfizer Completes Tender Offer For Icagen

GlaxoSmithKline has taken a stake worth £1.25 million ($2.06 million) in its biotech spin out company, Autifony Therapeutics, which aims to develop new treatments for hearing disorders. 

Under the terms of the agreement between the two companies, GSK will receive 850,000 A ordinary shares from Autifony in exchange for precandidate voltage-gated ion channel modulator compounds, which are thought to have potential in the treatment of hearing disorders, including noise-induced hearing loss and tinnitus. The agreement also includes the compounds’ associated patent applications and data for development in hearing loss. 

The investment will give GSK a 25.4% minority equity stake in the company, but this could increase in the future if a predetermined milestone is met. 

Autifony was created through a funding round comprising £5 million ($8.25 million) from UK investors Imperial Innovations and £5 million from SV Life Sciences, which has offices in the UK and the US. In a statement, Imperial Innovations explained that the partnership is a novel way to establish a new company.

“This is a creative approach to building new companies, leveraging established pharmaceutical assets together with the world class scientific expertise that exists at the UCL’s Ear Institute,” Susan Searle, CEO of Imperial Innovations, said in a 

According to the statement, the funding will be used to accelerate preclinical development, with the goal of initiating human trials in early 2013. In addition, the Autifony team will work with experts in auditory neuroscience at the UK’s University College London (UCL) Ear Institute.

“There are currently no pharmacological treatments available for hearing loss or tinnitus despite the increasingly large numbers of patients, both old and young, that suffer from these conditions,” Autifony’s cofounder and CSO, Charles Large, said in the statement. “Autifony represents an important opportunity to bring together our drug-discovery experience with the expertise of academic groups in this field, in particular the Ear Institute.  Autifony’s goal will be to find effective new medicines that can reduce the burden of suffering for this poorly served patient group.”

, GSK said it will be eligible to receive a further 550,000 A ordinary shares if Autifony meets a predetermined milestone. At this time, there will be further investment from the existing consortium and GSK will own 13.2% of Autifony on a fully diluted basis.

GlaxoSmithKline has taken a stake worth £1.25 million ($2.06 million) in its biotech spin out company, Autifony Therapeutics, which aims to develop new treatments for hearing disorders.