Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Adeline Siew, PhD

Endo Pharmaceuticals and GVK Biosciences (GVK BIO), a CRO based in India, have entered into an agreement to collaborate on the development of small molecules targeting an undisclosed protein. Using its discovery expertise, GVK BIO will deliver a clinical candidate and Endo will be responsible for the development and commercialization of the product. 

The partnership came out of GVK BIO's newly launched early discovery assets (EDA) program, which will focus on pain and inflammation, and is in line with Endo's specialties in pain, urology/oncology and endocrinology. 

"We are delighted to partner with Endo as it continues to build its discovery pipeline through external collaborations. This collaboration also confirms the value of our differentiated EDA concept, conceived to collaborate with pharmaceutical partners on discovery projects, from target to clinical candidates," said Manni Kantipudi, CEO of GVK BIO, in a 

Sandeep Gupta, PhD, Endo's senior vice-president of drug discovery and early development stated, "We are pleased to initiate this discovery collaboration with GVK BIO. With their world class infrastructure and an experienced scientific team, I have no doubt that they will execute on the program goals and add to our portfolio of development candidates that provide novel treatment options for the patients."

Earlier this month, GVK BIO entered into a joint partnership with Onconova Therapeutics to develop new drugs for cancer. The collaboration will align the research priorities and technological expertise of both companies to facilitate the advancement of Onconova's oncology assets from early discovery to clinical development stage. Onconova will provide two discovery targets with early chemical equity, while GVK BIO will use its multidisciplinary discovery platform to advance these programs through lead optimization and candidate selection for an investigational new drug application. This partnership with Onconova gives GVK BIO a growing share of the relevant discovery and development programs as they progress into clinical evaluation.

Articles

Endo Pharmaceuticals and GVK Biosciences (GVK BIO), a contract research organisation (CRO) based in India, have entered into an agreement to collaborate on the development of small molecules targeting an undisclosed protein. Using its discovery expertise, GVK BIO will deliver a clinical candidate and Endo will be responsible for the development and commercialisation of the product.

Endo Pharmaceuticals and GVK Biosciences Form Research Collaboration

Allergan and MAP Pharmaceuticals have entered into a definite merger agreement under which Allergan will purchase all of MAP’s outstanding shares for the price of $25.00 per share. The boards of directors of both companies have unanimously approved the transaction, which will be accomplished pursuant to a cash tender offer followed by a second step merger. The per share cash offer represents a 60% premium over MAP's closing stock price on January 22, and amounts to a total equity value of approximately $958 million, on a fully-diluted basis. The acquisition is expected to be completed in the first or second quarter of 2013.

MAP's orally inhaled drug Levadex is currently under review by FDA for the treatment of acute migraine in adults, and if approved will complement Allergan's own migraine treatment Botox. Allergan and MAP entered into a collaboration agreement in January 2011 to co-promote Levadex, contingent upon potential regulatory authority approvals in the US and Canada. 

"Through our dedicated employees at MAP Pharmaceuticals, we have made tremendous progress to date with our lead product candidate, Levadex, enabling us to realize substantial value for our stockholders through this transaction," Timothy S. Nelson, president and CEO of MAP Pharmaceuticals, said in a 

. "We are pleased that we and Allergan share similar values and a common vision in neuroscience that make for a strong cultural and scientific fit between our companies. We believe this acquisition by our partner Allergan will increase the potential for our product candidates to make a meaningful difference for patients we have worked so hard to serve." 

"One of the key drivers of Allergan's continued success is our focus on medical specialties where we have extensive knowledge of physician and patient needs, and can provide a broad portfolio of products," said David E.I. Pyott, Allergan’s chairman of the board, president and CEO. "During the past few years, Allergan has received regulatory approvals in 56 countries for Botox for use in the treatment of chronic migraine. As a result, thousands of patients who suffer from chronic migraine have benefited from this important treatment option. We plan to capitalize on this depth of expertise in Neurology as we continue the global development of Levadex as a potential acute treatment for migraine that is complementary to Botox and use MAP's proprietary drug particle and inhalation technologies to generate new pipeline opportunities." 

Allergan and MAP Pharmaceuticals have entered into a definite merger agreement under which Allergan will purchase all of MAP?s outstanding shares for the price of $25.00 per share.

Allergan to Acquire MAP Pharmaceuticals

With so many blockbuster drugs falling off the patent cliff, research-based drug companies are now embracing new development paradigms to increase R&D productivity. However, drug developers need to fully identify and address root causes of R&D inefficiency if they want to replenish their sparse R&D pipelines, according to the Tufts Center for the Study of Drug Development (CSDD). 

“Many companies are taking steps to improve clinical success rates and reduce the cost of new product development, including utilizing enhanced clinical trial designs, making greater use of biomarkers and adopting sophisticated statistical analyses,” said Kenneth I Kaitin, director of Tufts CSDD in a 

. “It’s a good start but in a world shaped by increased patent expirations, diminished cash flow, and fewer promising breakthrough products, companies will need to hone their efforts to streamline development.” 

Kaitin’s comments were made in connection with the release of Tufts CSDD outlook 2013 report on pharmaceutical and biopharmaceutical trends which highlighted the following near-term trends:

Exploratory drug development will replace conventional trial-and-error approaches. Drug companies will adopt new R&D paradigms based on biomarkers, modeling and simulation, novel formulation techniques, and adaptive clinical trial designs. 

Sponsors and contract research organizations will try to cut back on the number of investigative sites as well as the number of countries where trials are conducted to simplify clinical trial operating complexity. 

The biosimilar market is expected to grow significantly, especially with the abbreviated approval pathway for biological products that have been shown to be “interchangeable” with an FDA-approval biologic, which is required by the Patient Protection and Affordable Care Act.

Global concerns will shape prescription drug policy more than ever before, with international coordination growing in relation to the development of personalized medicines and drugs for neglected diseases.

Kaitin is, however, optimistic about the future of bioinnovation and said, “The emergence of open innovation models, where scientists worldwide openly share knowledge, and novel partnerships and alliances hold significant promise to transform the nature, pace, and cost of new drug development—to the benefit of patients, as well as to drug sponsors, their development partners, and investors.” 

With so many blockbuster drugs falling off the patent cliff, research-based drug companies are now embracing new development paradigms to increase R&D productivity.

Root Causes of R&D Inefficiency Must Be Identified: Report

Shire has signed an agreement to acquire Lotus Tissue Repair, Inc., a biotechnology company developing the first and only protein replacement therapy for the orphan disease, dystrophic epidermolysis bullosa (DEB). The acquisition is subject to customary government approvals. Shire will purchase Lotus Tissue Repair an upfront payment and contingent payments based on the achievement of certain safety and development milestones. 

The Human Genetic Therapies team at Shire will further develop Lotus Tissue Repair's lead product candidate, a proprietary recombinant form of human collagen type VII (rC7), for the treatment of DEB. This intravenous protein replacement therapy is currently in late-stage preclinical development. 

DEB is a genetic disorder, characterized by extremely fragile skin and recurrent blister formation resulting from minor mechanical friction or trauma. Severe cases of disease may include internal blistering of the mouth, esophagus, lower gastrointestinal tract, upper airway and genitourinary tract.

"DEB is one the most devastating orphan diseases, severely impacting the lives of patients and their families, many of whom have few or no treatment options other than palliative care," Dr. Philip J. Vickers, global head of R&D at Shire Human Genetic Therapies in a 

. "rC7 protein replacement therapy has the potential to provide a first-in-class disease-modifying treatment for these children. We plan to apply our proven ability to develop protein replacement therapies for rare genetic diseases to progress rC7 as a possible groundbreaking treatment that offers hope to patients with DEB."

"This acquisition of Lotus Tissue Repair by Shire further underscores the potential of this proprietary rC7 technology to dramatically change the treatment landscape for DEB patients and their families," said Dr. Mark de Souza, founding CEO of Lotus Tissue Repair. "We are thrilled that this program will become part of the innovative pipeline at Shire and the company's growing commitment to this patient community."

Shire has signed an agreement to acquire Lotus Tissue Repair, Inc., a biotechnology company developing the first and only protein replacement therapy for the orphan disease, dystrophic epidermolysis bullosa (DEB).

Shire Acquires Lotus Tissue Repair

Janssen Pharmaceuticals, Inc. and GlycoVaxyn AG have entered into a three-year agreement to collaborate on the research and development of a multivalent bacterial vaccine utilizing GlycoVaxyn's bio-conjugation technology. Janssen's affiliate, Crucell Holland BV, and GlycoVaxyn will develop the vaccine until proof-of-concept, after which Janssen follow on with late-stage clinical studies and worldwide commercialization. 

Under the terms of the agreement, GlycoVaxyn will receive an upfront, milestone payments, royalties on future sales, as well as reimbursement of research and development expenses. No financial details were disclosed. 

"Bacterial pathogens that exist in multiple pathogenic strains pose significant challenges for developing vaccines that target these strains," Michael Wacker, co-founder and chief scientific officer of GlycoVaxyn said in a 

.  "Our recombinant DNA-based vaccine technology is particularly well-suited for polyvalent conjugate vaccines and should make the development and commercialization of these vaccines more feasible and reliable."

Janssen Pharmaceuticals, Inc. and GlycoVaxyn AG have entered into a three-year agreement to collaborate on the research and development of a multivalent bacterial vaccine utilizing GlycoVaxyn's bio-conjugation technology.

Janssen and GlycoVaxyn Collaborate on Vaccine Development

Happy New Year! It's the beginning of another year in this digital age where science and technology continue to advance with leaps and bounds. And one can't help but ask, what awaits pharma in 2013? 

In answer to that question, we are confronted with various challenges in our individual projects and the evolving macro-environment of the industry. As an ex-scientist at the School of Pharmacy, University of London, where I earned a doctorate in pharmaceutics and drug delivery, I can fully appreciate the technical aspects involved in working to resolve problems in solubility and bioavailability, finding ways to enhance the delivery of therapeutics to targeted sites without causing detrimental effects on healthy cells, and developing stable formulations with favourable pharmacokinetic profiles. The real challenge, however, is resolving these issues in an increasingly cost-constrained marketplace.  

There is an escalating demand for medicines that are not only safe and effective, but that are also of good value, especially now that healthcare payers and governments have begun putting pricing pressure and cost constraints on new therapies. R&D pipelines, however, appear to be running dry with innovation on the decline and productivity hitting a plateau during the past decade. Drug development has evolved into a long and hard journey that is both costly and risky as we hear of more drugs failing in Phase III. On top of that, the industry is forced to confront its nemesis, the patent cliff, which sees blockbusters trampled by fiercely competitive generic drugs. 			

Yet, despite the gloomy outlook, the global pharmaceutical market is growing at a steady pace, even under such unfavourable economic circumstances. Sales reached $1.08 trillion in 2011 and, although the figures for 2012 have not yet been released, Business Monitor International projects that the market for medicines could be worth nearly $1.60 trillion by 2020. Indeed, pharma has proven its resilience time and time again, and should be commended for overcoming the many obstacles hurled at it, from tighter regulations and healthcare reforms, to more challenging market conditions and rising customer expectations. As an industry, it is still regarded as one of the strongest and wealthiest players of the global economy.  

 is committed to bringing you the latest trends and developments that shape the changing landscape of the global pharma industry, whether it's the rise of biologics, the new era of generics or advances in drug delivery, formulation and testing. So bring it on, 2013! 

Happy New Year! It's the beginning of another year in this digital age where science and technology continue to advance with leaps and bounds. And one can't help but ask, what awaits pharma in 2013?