Pharma News
US FTC clears Pfizer’s purchase of Hospira
Pharma giant Pfizer announced on 24 August 2015 that the US Federal Trade Commission (FTC) terminated the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to Pfizer’s pending acquisition of US-based injectable generics specialist and biosimilars maker Hospira.
ANI Pharma and IDT Australia collaborate on US generics
US-based brand-name and generic drugmaker ANI Pharmaceuticals (ANI) announced on 12 August 2015 that it had entered into a collaboration with generics company IDT Australia (IDT) to commercialize up to 18 previously marketed US generics.
Mergers between Watson/Actavis and ANI Pharma/BioSante
Mergers are once again on the agenda as companies strive to meet the constant demands of governments to cut costs and yet still make a profit.
AstraZeneca and Fujifilm Kyowa Kirin Biologics to collaborate on bevacizumab biosimilar
Japanese biosimilars maker Fujifilm Kyowa Kirin Biologics announced on 24 July 2015 that it had entered into an agreement with pharma giant AstraZeneca to establish a joint venture for the development and commercialization of its candidate biosimilar, FKB238.
Hikma to acquire Boehringer Ingelheim’s US generics business
Jordan-based drugmaker Hikma Pharmaceuticals (Hikma) announced on 28 July 2015 that it had made a deal with Germany’s Boehringer Ingelheim to acquire the latter’s US generics business: Roxane Laboratories and Boehringer Ingelheim Roxane (Roxane).
Lupin to expand US generics business with Gavis acquisition
Indian generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 23 July 2015 that it had entered into a definitive agreement to acquire US generics makers Gavis Pharmaceuticals and Novel Laboratories (Gavis).
Acquisitions for Endo and Strides
Endo Pharmaceuticals (Endo) and Strides Arcolab (Strides) are both looking at acquisitions as a way to expand their generics businesses.
Amneal to acquire Australian generics business from Actavis
Privately held US generics maker Amneal Pharmaceuticals (Amneal) announced on 31 March 2015 that it had made a deal with the Australian subsidiary of Actavis to acquire the Australian generics business of Actavis for an undisclosed amount.
Anticompetitive acquisition forces generics sale
US generics maker CorePharma has had to sell its rights of two generics in order to merge with fellow US drug company Impax Laboratories (Impax). The US Federal Trade Commission (FTC) ruled that Impax’s acquisition of CorePharma would have been anticompetitive unless CorePharma sold its rights and assets for pilocarpine, a drug used to treat dry mouth and glaucoma, and ursodiol, a treatment for liver and gall bladder diseases.
Teva finally makes bid for Mylan
In the wake of many rumours, Israeli generics giant Teva Pharmaceutical Industries (Teva) finally announced on 21 April 2015 that it had made a bid for US-based generics maker Mylan.
Growing investment in Vietnam
Cyprus-based generics company Medochemie is building its second factory in Vietnam. Construction on the site, which will occupy 44,700 square metres, is expected to be completed by the end of 2015 with operations commencing in early 2016.
Teva to buy Auspex Pharma, reinforcing CNS portfolio
Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 30 March 2015 that it would buy US biopharmaceutical company Auspex Pharmaceuticals (Auspex) for an equity value of US$3.5 billion.
India to set up pharma manufacturing clusters
The Indian Government is planning to set up pharmaceutical manufacturing clusters in order to reduce costs and make the industry more competitive.
Boehringer Ingelheim loses patent battle with India’s Cipla
German pharmaceutical company Boehringer Ingelheim (Boehringer) has lost its patent on the Spiriva respiratory drug in India. The Indian patent office has agreed with the Indian drugmaker Cipla that Boehringer’s Spiriva patent was obvious and was not an invention under India’s patent laws.
Indian Government to launch own brand of generics
Not happy with its current control over the price of drugs in the country, the Indian Government has announced plans to launch its own brand of low cost generics.
Canada clamps down on companies failing to post drug shortage information
The Canadian Government has made it mandatory for drug companies to report actual and anticipated drug shortages. A voluntary system that had been in place was not working well enough, said the country’s Health Minister, Rona Ambrose.
Pfizer sets to lead biosimilars and generics markets
Pharma giant Pfizer has announced it is to buy injectable generics specialist and biosimilars maker Hospira for US$17 billion. The products acquired in the deal will be integrated into Pfizer’s generics unit, Global Established Pharmaceutical (GEP).
Mylan on track to acquire Abbott generics and expand role in women’s health
The European Commission (EC) has approved Mylan’s acquisition of Abbott Laboratories' Non-US Developed Markets Specialty and Branded Generics Business (Abbott EPD-DM), subject to conditions. US-based generics manufacturer Mylan will have to sell off a number of its businesses in France, Germany, Ireland, Italy and UK in order to satisfy European Union merger regulations.
Actavis to buy UK generics maker Auden McKenzie
US generics maker Actavis announced on 26 January 2015 that it had agreed to buy UK generics maker Auden McKenzie. The deal will propel Actavis into the top position in the UK for generics suppliers, placing it in third position in the UK overall.
Amgen’s approach in the biosimilars market
Biotech giant Amgen now has a biosimilars programme that includes nine different molecules [1]. A representative from Amgen has spoken to GaBI about the company’s venture into biosimilars [2].
Top 10 most read GaBI Online articles in 2014
2014 was once again a busy year for biosimilars, ranging from revision of regulatory guidelines to naming and extrapolation. Biosimilars remain the hot topic for GaBI Online during 2014 and, in fact, all 10 of the most read articles concern biosimilars.
Cipla makes deal with Serum Institute for vaccines in Europe
India-based generics maker Cipla announced on 20 November 2014 that it had signed a deal with the Serum Institute of India (Serum Institute) to distribute vaccines in Europe.
Actavis buys Allergan and joins pharma top 10
On 17 November 2014, US generics maker Actavis announced that the company had made a deal to acquire botox-maker Allergan for US$66 billion.
Xbrane signs biosimilar optimization deal with Indian pharma firm
Swedish biotech company Xbrane Bioscience (Xbrane) has signed an agreement with a global Indian pharmaceutical company to assist them in developing an optimized production system for a specific biosimilar that will be marketed worldwide. The aim is to help the client reduce production costs in order to gain a competitive advantage in the biosimilar market.
Cipla Medpro to collaborate with Teva for generics in South Africa
India-based generics maker Cipla announced on 8 October 2014 that it had made a collaboration deal with Israel’s Teva Pharmaceuticals for sales and distribution of the latter’s generic drugs in South Africa.
Supernus sues Actavis over generic Trokendi XR
US-based central nervous system specialist Supernus Pharmaceuticals (Supernus) announced on 2 Oct 2014 that it had sued generics maker Actavis for infringement of three patents covering its antiepileptic drug Trokendi XR (extended release topiramate). The three US patents (8,298,576, 8,298,580, and 8,663,683) cover once-a-day topiramate formulations and methods of treating seizures using those formulations.
Generics maker IGI Labs gains rights to AstraZeneca injectables
Speciality topical generics maker IGI Laboratories (IGI Labs) announced on 25 September 2014 that it had acquired the rights for 18 drugs from AstraZeneca.
India suffers HIV drug shortages
Supply bottlenecks and late payments to drugmakers have hit HIV treatment supplies across India, according to reports in the Indian press. The drug shortages, which affect those least able to pay, have seen some government distribution centres running out of drugs altogether.
Biocad to be taken over by Russian investment firm
Russia’s biggest drugmaker, Pharmstandard, and investment company, Millhouse LLC, have said that they are planning to buy 70% of Russian biosimilars developer Biocad.
Amgen and Pfizer seek deal with Russian non-originator biologicals firm
Russian biotechnology company Biocad is reported to be attracting offers from US-based Pfizer and biotechnology giant Amgen.
Strides and Shasun merger aims to spread risk
In the current climate of increasing scrutiny against Indian generics manufacturers by the US Food and Drug Administration (FDA), Indian generics maker Strides Arcolab (Strides) and India-based active pharmaceutical ingredient (API) maker Shasun Pharmaceuticals (Shasun) have announced a ‘risk-spreading’ merger.
Cipla and S&D Pharma make generics deal for Czech Republic and Slovakia
India-based generics maker Cipla has partnered with S&D Pharma to launch affordable, high quality generics in the Czech Republic and Slovakia.
Patients at risk from UK drug shortages
Ongoing drug shortages in the UK have led to 80% of general practitioners (GPs) surveyed reporting that their workloads have increased in the last year. A third of doctors say their patients have been harmed or been negatively affected if a second choice has had to be prescribed.
Investor principles on biosimilars gained support
Amgen and Novartis (parent company of Sandoz, a leader in the biosimilars field) have both come out in support of a set of principles on biosimilars laid down by a coalition of 19 institutional investors.
Branded drugmaker could be sued for generic’s side effects
The Alabama Supreme Court has ruled, for the second time, that Pfizer could be sued for damages allegedly caused by its heartburn drug Reglan (metoclopramide), even if the plaintiff had only taken a generic version of the drug. The ruling follows a rehearing requested by Pfizer, which failed to overturn the original ruling.
Generics shortages continue to rise in the UK
There is growing anxiety around the supply of generic medicines in the UK, according to a statement released by the country’s All-Party Pharmacy Group (APPG). The problem is worse than it was two years ago [1], say the cross-bench Members of Parliament who make up the group, and it is not being addressed by the Department of Health’s (DoH) supply chain forum which was set up to address this very issue.
Generics deals for Mylan, Pfizer and Sun Pharma
Not to be beaten by biosimilars manufacturers, generics makers are also jumping on the ‘deals’ bandwagon, with a plethora of collaborations announced in the past weeks.
Endo to buy generics maker DAVA
Specialty pharmaceuticals maker Endo Health Solutions (Endo) announced on 24 June 2014 that it had reached a definitive agreement to acquire generics maker DAVA Pharmaceuticals for US$575 million in cash, with another US$25 million up for grabs depending on the achievement of certain sales milestones.
Abbott to buy Russian generics firm
US-based pharma company Abbott Laboratories (Abbott) announced on 23 June 2014 that it had signed a definitive agreement to acquire Russian generics maker Veropharm.
Pfenex looking for funding for its biosimilars pipeline
US biotechnology firm Pfenex is looking to raise more than US$45 million to further its biosimilars pipeline.
Views on biosimilars at Amgen and Actavis
Biotech giant Amgen and US generics maker Actavis entered into a collaboration for the development and commercialization of several cancer antibody biosimilars back in December 2011 [1]. Now the two companies have spoken to GaBI about their views on biosimilars and their biosimilar plans [2].
Top 10 most read GaBI Online articles in 2013
2013 was a busy year with lots of developments in the biosimilars arena, ranging from revision of regulatory guidelines to new biosimilar approvals. Biosimilars remain the hot topic of the year for GaBI Online during 2013 and in fact all 10 of the most read articles concern biosimilars.
Abbott expands generics business in Latin America
US-based pharma company Abbott Laboratories (Abbott) announced on 16 May 2014 that it was expanding its presence in Latin American and increasing its branded generics portfolio with the acquisition of CFR Pharmaceuticals (CFR).
Pamplona investment group buys majority share in Alvolgen
Specialist investment manager Pamplona Capital Management (Pamplona) announced on 2 April 2014 that it had acquired a majority stake in US generics company Alvogen, one of the fastest growing generics companies in the pharmaceutical industry.
Actavis to acquire generics from Akorn
US generics major Actavis announced on 17 April 2014 that it had made a deal with Akorn and Hi-Tech Pharmacal (Hi-Tech) to buy five of their products.
UK court invalidates Herceptin patents
A High Court in the UK has overturned two key patents on Roche’s breast cancer blockbuster Herceptin (trastuzumab).
Sun Pharma to acquire Ranbaxy creating 5th largest generics firm
India-based Sun Pharmaceutical (Sun Pharma) announced on 6 April 2014 that the company had agreed to acquire rival generics maker Ranbaxy Laboratories (Ranbaxy) in an all-stock deal worth US$3.2 billion.
Actavis buys Thai generics company
US generics major Actavis has acquired Silom Medical Company, a privately held generics firm focused on developing and marketing therapies in Thailand, for around US$100 million in cash.
US FTC hopes to collect US$1 billion from pay-for-delay settlement
The US Federal Trade Commission (FTC) is looking to collect more than US$1 billion from a settlement with pharmaceutical companies it has sued for their part in what the FTC terms ‘pay-for-delay’ deals.
Anticompetitive practices come under scrutiny in Australia
The Australian Competition and Consumer Commission (ACCC) has started proceedings in the Federal Court against Pfizer Australia (Pfizer) alleging that offers made by Pfizer to pharmacies before the expiry of the patents for its blockbuster cholesterol-lowering drug Liptor (atorvastatin) were anticompetitive.
Actavis to acquire specialty drugmaker Forest Labs
US-based generic drugmaker Actavis is set to grow even bigger, with the acquisition of US-based Forest Laboratories (Forest Labs), according to an announcement by the companies on 18 February 2014.
Actavis sells interest in China
US generic drugmaker Actavis has sold its interest in its Chinese subsidiary based in Foshan, Guangdong, to Zhejiang Chiral Medicine Chemicals. Actavis, the second biggest generic drugmaker by market capitalization, intends to continue further commercial operations in China in collaboration with its preferred business partners.
Aurobindo to acquire seven generics businesses from Actavis
US generics maker Actavis and Indian generics maker Aurobindo Pharma (Aurobindo) announced on 17 January 2014 the signing of an offer for Aurobindo to acquire generics commercial operations in seven markets in Western Europe from Actavis.
Pfizer’s generics business up for grabs
In 2013, Pfizer, the world’s largest drugmaker, split its business into two brand-name drug units and a generics business. Now it seems the generics unit, or its ‘established products’ unit, is being circled for a potential takeover bid.
Pricing dispute causing drug shortages in Pakistan
Pharmaceutical manufacturers in Pakistan are warning the Pakistan Government that shortages in life-saving drugs are a result of the ongoing dispute over drug prices.
Ireland’s IPHA hits back at high drug prices claim
The Irish Pharmaceutical Healthcare Association (IPHA) has hit back at statements from the European Commission’s (EC’s) troika that drug prices in the country are unjustifiably high.
Health Canada approves generic oxycodone despite fears of abuse
Canada’s drug regulator Health Canada has approved a generic non-crush resistant form of oxycodone, despite the fact that US officials have been urging their Canadian counterpart to ban such formulation of the powerful painkiller.
Ireland high drug prices cannot be justified
The European Commission’s troika mission to Ireland has told Government TDs (Members of Parliament) that the cost of pharmaceutical drugs in the country cannot be justified. Drug prices in the country have been found to be at least three times more expensive than in the UK.
EMA launches public catalogue of drug shortages
The European Medicines Agency (EMA) announced on 4 November 2013 the launch of its public catalogue on supply shortages of drugs.
FDA announces two actions to combat drug shortages
The US Food and Drug Administration (FDA) announced on 31 October 2013 that it is taking two important actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages.
Australia should not copy New Zealand’s drug pricing system
Australia should resist ongoing pressure to adopt a New Zealand-style model of medicines funding, according to Medicines Australia, a group that represents originator manufacturers.
US state introduces law to allow meds to be bought over Internet
On 9 October 2013, the US state of Maine introduced a law allowing its residents to purchase foreign prescription drugs over the Internet.
India approves Mylan’s purchase of Agila
Generics giant Mylan announced on 3 September 2013 that its proposed acquisition of generics injectables maker Agila Specialties (Agila) from Strides Arcolab for Rs 5,168-crore (US$1.6 billion) had been cleared by the Indian Government.
Johnson & Johnson warns of shortages of cancer drug Doxil
Janssen Pharmaceutical Companies (Janssen), a division of healthcare giant Johnson & Johnson, has warned of impending shortages of its ovarian cancer drug Doxil (doxorubicin).
Sandoz launches new device for its biosimilar somatropin
Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 23 September 2013 the launch of a new delivery device for its biosimilar somatropin product (Omnitrope) in the UK.
Akorn to buy Hi-Tech Pharmacal for US$640 million
Generic eye-drugmaker Akorn has entered into a deal to buy Hi-Tech Pharmacal (Hi-Tech) for US$640 million in cash to expand into oral liquids and ointments, including cold and cough treatments.
Endo to buy specialty generic drugmaker Boca Pharmacal
Specialty pharmaceutical maker Endo Health Solutions (Endo) announced on 28 August 2013 that its generics subsidiary, Qualitest, has agreed to buy specialty generic drugmaker Boca Pharmacal (Boca) for US$225 million in cash.
Actavis and Bioton form joint venture for insulin
Icelandic generics manufacturer Actavis announced on 30 January 2012 that it had formed a joint venture company with Polish biotechnology company Bioton for the development and registration of insulin products, including analogue insulins.
Philippines urged to import drugs from Bangladesh
The Prime Minister of Bangladesh, Ms Sheikh Hasina, on 5 May 2013 urged the Philippines to import pharmaceutical products from Bangladesh, particularly for the countries governmental hospitals and clinics, due to the significant cost-savings to be made.
Generics manufacturers increase investment in injectables
Generic drugmaker Zydus Cadila, the fifth largest pharmaceutical company in India, is set to invest about US$15.8 million in building an FDA-approved injectables-manufacturing plant. The news in August 2013 came just as Aurobindo Pharma announced plans to spin-off its injectables business to strengthen that side of its operations further.
Fresenius Kabi sets up generics joint venture in Indonesia
Fresenius Kabi, the generics unit of healthcare giant Fresenius, announced on 19 August 2013 that it had set up a joint venture with Indonesia-based PT Soho Global Health, acquiring a 51% share in its subsidiary PT Ethica Industri Farmasi.
Perrigo expands global ambitions with Elan buy
US-based generics maker Perrigo Company (Perrigo) announced on 29 July 2013 that it would acquire Irish biotechnology company Elan Corporation (Elan) for US$8.6 billion.
Pfizer prepares to split off generics business
Pfizer, the world’s largest research-based pharmaceutical company, has announced plans to split off its generics drug business into a separate commercial operation. News of the plans came as the company reported its second quarter 2013 results at the end of July.
Aspen makes deals with Merck and GSK
Generics manufacturer Aspen Pharmacare Holdings (Aspen) is expanding its brand-name business, first signing a deal with Pharma giant Merck, and then offering to buy two brand-name heart medications from GlaxoSmithKline (GSK).
CFR pharma expands global ambitions with Adcock bid
Chile-based CFR Pharmaceuticals (CFR) has plans to become a global drugmaker. In its latest efforts it has made a US$1.3 billion cash-and-share offer for South Africa’s second-largest generics drugmaker Adcock Ingram (Adcock).
UK plans to cut drug prices by up to 20%
The UK’s Department of Health (DoH) has launched a consultation to strengthen the statutory pharmaceutical pricing scheme, which covers the prices the National Health Service (NHS) pays for brand-name drugs not covered by the voluntary Pharmaceutical Price Regulation Scheme (PPRS). The consultation is seeking views on a price cut on drug prices of between 10% and 20% to ensure the NHS continues to get good value for money.
Viagra generics hit the market in Europe
The patent on Pfizer’s blockbuster erectile dysfunction drug Viagra (sildenafil) expired on 21 June 2013 in the UK, along with several other European countries.
Nigeria needs to combat fake drugs and ageing facilities
Nigeria has ageing drug-manufacturing facilities and a problem with imports of fake drugs, according to Mr Olakunle Ekundayo, Group Managing Director, Drugfield Pharmaceuticals.
Sun Pharma looking to buy Sweden’s Meda
India-based Sun Pharmaceutical Industries (Sun Pharma) is reportedly in talks to acquire Swedish drugmaker Meda for US$5–6 billion.
Actavis makes definitive agreement with Warner Chilcott
US generic drugmaker Actavis (formerly Watson) and Irish drugmaker Warner Chilcott announced on 20 May 2013 that the two companies had entered into a definitive agreement under which Actavis will acquire Warner Chilcott in a stock-for-stock transaction valued at approximately US$8.5 billion.
