Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.

Generic Pharmaceuticals Market — A Global Analysis

, explains that drugs worth $150 billion will go off-patent between 2010 and 2017, helping to propel the generic-drugs market from revenues of $123.85 billion in 2010 to an estimated $231 billion in 2017. However, as competition intensifies, generic-drug manufacturers will need to carefully consider their product segments and the appropriate time for market launch. Companies will also have to deal with increasingly stringent regulations and price-control measures from governments, mainly being driven as a result of the aging population and the prevalence of chronic diseases.

“Large multinational generic firms need to adopt a differentiated approach by opting for products with technologically challenging formulations, products which require significant regulatory support and products with limited availability of active pharmaceutical ingredients,” Aiswariya Chidambaram, a research analyst at Frost & Sullivan, said in a press statement.

According to the report, some companies have forged strategic alliances with branded pharma for the marketing rights and exclusivity to certain generic blockbusters, such as Lipitor and Crestor, among others. Many market-leading generic-drugs companies, such as Teva, Sandoz, and Mylan, are also increasingly focusing more on biosimilars, which provide a competitive edge and offer potentially huge profit margins. In addition, difficult-to-produce generic drugs and speciality products are also attracting greater attention. Aiswariya notes that, “Small and medium-sized firms should focus on products with relatively higher profit margins.”

Articles

Global Market Boom for Generic Drugs

Sanofi will co-invest in start-up biotech company Warp Drive Bio by providing financial funding and access to its strains library and expertise in natural products. Two US venture capitalist firms, Third Rock Ventures and Greylock Partners, will also invest in the start up, with all three offering funding that could amount to $125 million in the next five years, including an equity investment of $75 million.

War Drive Bio, which will focus on using proprietary genomic technology to discover drugs of natural origin, will remain an independent company, and retain strategic direction, operational management and the right to develop and commercialise assets. However, Sanofi will be granted certain access rights to Warp Drive Bio’s technology and products on a worldwide basis.

According to a press statement, advances in microbial genomics have revealed “vast treasure troves” of novel, natural drug products hidden in microbes.

 “Prior to Warp Drive Bio, no one had created a comprehensive discovery engine that selectively mines from nature those products with transformative pharmaceutical potential,” Gregory L. Verdine, a venture partner at Third Rock Ventures and co-founder of Warp Drive Bio, said in the statement. “Warp Drive Bio has developed that capability and is using it to discover powerful next-generation drugs that target the central circuitry of human cells in completely new ways.”

The company has been assembling an array of technologies to create a platform for identifying potential drug candidates using microbiology, next generation sequencing, cutting-edge bioinformatics and chemo-informatics. The process involves a genomic search engine and customised search queries that enable natural products within micro-organisms to be identified on the basic of their distinctive genomic signature. 

“This innovative collaboration between Sanofi and Third Rock Ventures provides the opportunity to build significant value and the potential for venture capital levels of return,” said Alexis Borisy, partner at Third Rock Ventures and interim CEO of Warp Drive Bio. “Importantly, it also enables us to advance and accelerate the development of our proprietary genomics platform, unlock ‘nature’s drugs’ and, ultimately, create breakthrough therapies for patients.”

Sanofi will co-invest in start-up biotech company Warp Drive Bio by providing financial funding and access to its strains library and expertise in natural products.

Sanofi Boosts Biotech Start Up

GlaxoSmithKline has faced intense media scrutiny this week after being fined approximately 72 650 Euros by a court in Argentina for allegedly conducting unethical clinical trials on children for the company’s pneumococcal vaccine, Synflorix.

		I always seem to be writing about GSK in my blogs but this is a much more sombre subject compared with the recent news of GSK CEO Andrew Witty’s knighthood. This week’s attention on GSK is focused on the COMPAS (Clinical Otitis Media and PneumoniA Study) study, which involved almost 24 000 children and was completed in Argentina in June 2011. The fine issued by the Argentinean National Administration of Medicines, Food and Medical Technology (ANMAT) related to administrative procedures in place for the study in 2007 and 2008. According to media reports (

), some consent forms were signed by illiterate parents or people who did not have custody of the children. Claims have also been made that some children feeling unwell after vaccination were not seen by doctors.

		Fourteen children are reported to have died during the study. Because the trial involved children, it is an extremely sensitive and emotional topic that has evoked strong reactions from some 

 that accuse GSK of “killing” babies and “experimenting with humans”.

		But there are two sides to every story. Personally, I don’t believe that any reputable pharmaceutical company would experiment on humans.

 that the fine relates to administrative procedures and “does not question the safety of the study vaccine”. Indeed, according to the statement, any deaths in the study were thoroughly investigated and both an independent data monitoring committee and ANMAT both concluded that none of the deaths were related to the vaccine.

		The administration irregularities with obtaining informed consent were identified by GSK in 2007 and 2008 as part of routine monitoring, which takes place at 6-week intervals.

		“The company proactively reported these findings to ANMAT and immediately put in place a corrective action plan which involved reconfirming informed consent of patients in the study and retraining doctors… where necessary,” explained GSK’s press statement. “The safety of patients participating in the study was not put at risk and ANMAT agreed that the study could continue as planned.”

		Some media sources have also accused GSK - and other Western pharma companies - of taking advantage of developing countries to experiment with new treatments. In the case of GSK’s Synflorix, however, developing countries are a logical choice for a clinical trial. Estimates from the World Health Organisation claim that more than 500,000 young children die each year from pneumococcal infection, with the vast majority of these deaths occurring in developing countries. The 

 also explains that although a vaccine against pneumococcal disease has been widely used in Europe and the US since 2000, it was not optimal for developing countries because it lacked different strains of pneumococcal bacteria that are common in developing countries.

		Although Argentina is not really considered a developing country, it still has a large number of people living in poverty and pneumococcal disease is a significant health burden.

		GSK says that it “respectfully disagrees” with the court ruling in favour of ANMAT and will appeal to the Supreme Court of Argentina. However, if unethical practices did take place during the trial then GSK has said it will pursue the matter.

		“We are also concerned by allegations that treatment was delayed for some children in the trial if they were unwell and, if true, these events are shocking… we will be looking into this further,” said the GSK statement.

GSK in Spotlight for Alleged Unethical Trials

Bristol-Myers Squibb (BMS) has signed an agreement to acquire the clinical-stage biotechnology company Inhibitex in a deal worth approximately $2.5 billion. The transaction will provide BMS with a potential candidate currently in Phase II development for the treatment of hepatitis C. The candidate, INX-189, is an oral nucleotide polymerase inhibitor that has exhibited potent antiviral activity.

 from the companies, nucleotides/nucleosides are emerging as an important class of antivirals that may play a crucial role in the future of direct-acting antiviral-only combination approaches to the treatment of hepatitis C.

“This transaction puts INX-189 and the company’s other infectious disease assets in the hands of an organization that can more optimally develop them,” Russell Plumb, president and CEO of Inhibitex, said in the statement. “Bristol-Myers Squibb’s expertise in antiviral drug development, and its existing complementary portfolio, will assure that the potential of INX-189 is realized as part of future oral combination therapies.”

BMS’s CEO Lamberto Andreotti added that the acquisition represents an important investment in the company’s long-term growth. Currently, there is significant unmet medical need in treatments for hepatitis C.

“Bristol-Myers Squibb continues to drive advances in the field of hepatitis C R&D through internal development and selective partnerships,” Elliott Sigal, executive vice president, chief scientific officer and president, R&D, at BMS, said in the statement. “The addition of Inhibitex’s nucleotide polymerase inhibitor to our own promising portfolio... brings additional options to develop all-oral regimens with better cure rates, shorter duration of therapy, and lower toxicity than the current standard of care.”

BMS is offering Inhibitex shareholders $26 in cash per share, which represents a huge premium over Inhibitex’s closing price last Friday of $9.87. The transaction has been approved by both companies’ boards of directors and Inhibitex has recommended that its shareholders tender their shares. However, according to a 

 from the Pomerantz Law Firm there is concern among shareholders that the Inhibitex directors may be “breaching their fiduciary duties by failing to adequately shop the company and maximize shareholder value.” The firm adds that BMS stands to gain a “very lucrative position” in the hepatitis C drug industry. Although shareholders will receive $26 per share, at least one other analyst has set a target price of $34 per share.

The agreement also provides for the companies to effect, subject to customary conditions, a merger following the tender offer. There is also a provision under which Inhibitex has agreed not to solicit any competing offers.

Bristol-Myers Squibb (BMS) has signed an agreement to acquire the clinical-stage biotechnology company Inhibitex in a deal worth approximately $2.5 billion. The transaction will provide BMS with a potential candidate currently in Phase II development for the treatment of hepatitis C.

BMS to Acquire Inhibitex for $2.5 Billion

First of all, I wish all of you a very happy new year! The pharma industry and its workers have been through a lot of hardships in recent times with huge job losses, eroding profits and drying pipelines. A lot of gloomy predictions have been made about 2012 (including ongoing economic woes and the end of the world) but let’s hope that this year finally brings good times for pharma as it seems that the industry is well overdue for a successful year.

		For Andrew Witty, the CEO of British pharma giant GlaxoSmithKline, the year is definitely off to a good start after he was knighted for services to the UK economy and pharmaceutical industry. Sir Andrew as he will now be known received the royal recognition in the 

. Almost 1000 people received awards of varying kinds. 

		This year, science and healthcare were well represented with other recipients of knighthoods including, among others, two physics professors, Professor Andre Konstantin Geim and Professor Konstantin Novoselov from the University of Manchester, Professor Stephen Robert Bloom from Imperial College London for services to medical science, and Dr Venkatraman Ramakrishnan from the Medical Research Council’s Laboratory of Molecular Biology for services to molecular biology. Julie Moore, the chief executive of the University hospitals Birmingham NHS foundation was also made a dame. Varying awards were also given out to other researchers and other pahrmaceutical industry particiants, including Richard Barker, the former director general of the Association of the British Pharmaceutical Industry (ABPI). There’s a full list available in 

		If you’re not familiar with the UK’s honours list, it’s a way of recognising merit, gallantry and service to the country. The lists are published twice a year at New Year and on the Queen’s official birthday in mid-June. The lists always comprises a number of film and sports celebrities, but it also reflects a range of skills and talents from across the UK.

		The awards are also generally subject to a large amount of cynicism. For instance, 

 says, “Cynics may be suspicious of the timing of this flurry of biopharma-focused decorations. They came only a couple of weeks after the UK government outlined its new Life Sciences Strategy, in which much hope was placed on the sector helping to pull the UK economy out of the doldrums.”

		I’ve also read some very cynical pieces that talk about the involvement of the British government in the honours process and the fact that Witty serves on an economic committee for the UK’s Prime Minister David Cameron.

 on the honour’s list this year has focused on other award recipients, such as Paul Ruddock who received a knighthood for services to the arts for his work as chairman of the Victoria and Albert museum. Ruddock’s hedge fund management company Landsdowne Associates made around £100 million after betting on the collapse of the bank Northern Rock. News reports have also pointed out that Ruddock has donated nearly £500,000 to the Conservative party. Some scathing has also been directed at the knighting of Paul Bazalgette, a TV executive who brought 

on our sister site Pharmaceutical executive points out, Sir Andrew could be seen as a bit of a knight in shining armour compared with other names on the list! GSK has pledged loyalty to the UK economy and has also sought to help developing economies by improving access to medicines. He’s also looking at some innovative ways to improve the company’s R&D by partnering with the McLaren Group. The knighthood will certainly be a good thing for GSK’s reputation, which has taken a bit of battering in the last year. In 2011, the company had to pay £1.6 billion to settle litigation cases concerning Avandia, which has been banned in Europe, while in the US the company has agreed to pay $3 billion to settle investigations into the way the company marketed certain products.

GlaxoSmithKline Agrees in Principle to $3-Billion Settlement with the US Government

Pfizer, GSK Commit to Supplying Developing World with Vaccines

GSK CEO Knighted

Alexion Pharmaceuticals has signed an agreement to acquire all the capital stock of the biopharmaceutical company Enobia Pharma in a $610-million all-cash transaction. The acquisition will provide Alexion with a potential treatment for patients with hypophosphatasia, a rare genetic metabolic disease that currently has no approved treatments. 

"Hypophosphatasia is an ultra-rare and life-threatening disease, and those patients who survive live with debilitating morbidities including skeletal deformity, severe muscle weakness, and progressive damage to vital organs," Leonard Bell, Chief Executive Officer of Alexion, said in a 

Enobia Pharma’s lead product candidate for hypophosphatasia, ENB-0040 (asfotase alfa), is a human recombinant targeted alkaline phosphatase enzyme-replacement therapy. The compound is currently in Phase II clinical development, and was awarded orphan drug designation in the EU and the US in 2008 and 2009 respectively. According to the joint press statement from the companies, the compound has, to date, showed promising results in Phase II in infants and juveniles. Hypophosphatasia can affect all ages, but 50% of infant with the disease do not survive beyond one year of age.

In addition to the upfront $610 million, Alexion will also pay $470 million in cash upon achievement of various regulatory and sales milestones. The transaction has been approved by the boards of both companies and is expected to be completed in the first quarter of 2012. Alexion will finance the acquisition through cash on hand and $300 million of committed bank debt.

Alexion Pharmaceuticals has signed an agreement to acquire all the capital stock of the biopharmaceutical company Enobia Pharma in a $610-million all-cash transaction.