The US Department of Health and Human Services has marked the recent approval of the 100th antiretroviral drug to be approved through the PEPFAR programme. Ironically, by the time the FDA marked the event, the 101st product had already received approval. PEPFAR, the President's Emergency Plan for AIDS Relief, was introduced by President Bush in 2003 and has a remit to work in partnership with host nations through to fiscal year 2013 to support treatment for at least three million people, prevention of 12 million new infections and care for 12 million people, including five million orphans and vulnerable children. The programme allows the FDA to review antiretroviral drug applications on an expedited basis, with the aim of fast-tracking the approval of drugs in order for them to be used in developing countries, rather than the US. Most applications are generic, and most approvals are tentative, as they are for drugs which are still protected by patents in the US, and thus the generics cannot be marketed in the US.
A look at the drugs approved produces an interesting picture. The first to be approved was Barr Laboratories' didanosine capsules, which gained tentative approval on 3rd December 2004. This proved not only to be Barr's first and last drug approved under the PEPFAR programme, but also stands out as the only drug to enter the programme from an American company. In total, 13 companies have provided the 101 drugs, and of those 13, ten are Indian firms. Asides from Barr, the other two firms which are not based in India are Aspen Pharmacare, based in South Africa, and Huahai US, based in China. One of the Indian firms listed, Matrix Laboratories, is now majority-owned by the US' Mylan, but was an entirely Indian firm at the time many of its products were submitted and approved. Matrix also took the honours for both the 100th and 101st drugs to be approved under the programme. The dominance of Indian firms in the lists underscores the role India has carved out in producing generic antiretrovirals, and included in the list are some of the country's largest generic pharmaceutical manufacturers, including Ranbaxy Laboratories and Cipla, as well as smaller companies, such as Aurobindo Pharma, Emcure Pharmaceuticals and Hetero Drugs. Aurobindo has emerged as the company with the most drugs approved under PEPFAR, with 31 of the 101.
Quite why so few US generic firms have had antiretrovirals approved under the PEPFAR programme is curious. A quick look at the FDA's information for approved or tentatively approved antiretrovirals shows that, as with the PEPFAR programme, generic versions of these drugs are dominated by Indian firms, with only Barr and Roxane Laboratories standing out. The most likely reason is undoubtedly money. US firms will need to spend money to develop generic antiretrovirals, especially as many companies do not have any experience with antiretrovirals, and as most of these are still protected by patents in the US and thus cannot be marketed there, there will be no immediate prospect of returns. Of course, the patents will eventually expire, but at that point, home grown firms will have already lost the chance of marketing exclusivity to the multitude of Indian firms which have tentative approvals already; financial returns will therefore be minimal. However, neither the domestic nor international markets for antiretrovirals are getting any smaller, and whilst such drugs may not see the stellar returns promised by blockbusters such as fluoxetine has in the past, they may well provide a small but steady income, particularly in the US and other developed nations.
Ian Platts - Editor, World Generic Markets
Monday, October 26, 2009
Friday, October 9, 2009
Goldshield bidding war
A bidding war broke out in September 2009 over Goldshield Group, the UK-based pharmaceutical and consumer health company. The battle is being fought out by two investment vehicles, AIT Investments and Midas Bidco.
Goldshield began life in 1991, gained its first marketing authorisation for a product it had developed itself in 1996, and floated on the London Stock Exchange in 1998. The Group was founded by two brothers, Ajit and Kirti Patel, along with a third partner, Shane Gogerly. In recent years, Goldshield was one of a number of companies to face investigations over alleged price fixing by both the Serious Fraud Office and the NHS. Although the cases ultimately collapsed, the investigations did see both Ajit Patel and Kirti Patel step down from the firm's Board in order to fight allegations levelled at them; Kirti Patel now occupies the position of Group Executive Director in the company. Perhaps ironically, given the legal battles the firm has faced, Goldshield's current Non Executive Chairman is Dr Keith Hellawell, who in previous years was a Chief Constable for two British police forces and in the late 90s was responsible for the UK's anti-drugs policy. For its most recent fiscal year, ended March 2009, Goldshield reported revenues worth £98.4 million (US$156.9 million), with profit after tax of £13.9 million (US$22.1 million). This was a significant improvement on the revenues of £84.9 million and profit after tax of £6.3 million reported for the previous fiscal year.
Ajit Patel is now involved in one of the parties bidding to acquire Goldshield, AIT Investments, which was the first to announce an offer. AIT describes itself as a newly-incorporated company formed by the Fuhrer family for the purpose of implementing the acquisition of Goldshield. The Fuhrers are an Israeli family which own and control the Neopharm group of companies, which market ethical pharmaceuticals and branded consumer healthcare products.
The other bidder for Goldshield is Midas Bidco, an investment vehicle set up by Goldshield's management team; involved in this bid is Goldshield co-founder, Kirti Patel; the two brothers are thus facing off over control of the company they set up and then had to withdraw from in order to fight the price fixing allegations.
AIT commenced bidding for Goldshield with an offer of 440 pence per share, valuing the company at some £162.1 million (US$257.1 million). In response, Midas announced it had put financial backing in place to allow it to make an offer above 440 pence per share. AIT hit back, raising its offer to 450 pence per share, valuing the company at £165.7 million (US$262.8 million). Bidco then upped its offer to 460 pence per share, making the firm worth £169 million (US$268.0 million). In the latest turn, AIT then increased its bid on 2nd October to 480 pence per share, which would value Goldshield at £176.8 million (US$280.4 million). At the time of writing, this is where the bidding rests. However, there is no doubt that the deal, which has pitched two brothers against each other, is not yet done.
Ian Platts - Editor, World Generic Markets
Goldshield began life in 1991, gained its first marketing authorisation for a product it had developed itself in 1996, and floated on the London Stock Exchange in 1998. The Group was founded by two brothers, Ajit and Kirti Patel, along with a third partner, Shane Gogerly. In recent years, Goldshield was one of a number of companies to face investigations over alleged price fixing by both the Serious Fraud Office and the NHS. Although the cases ultimately collapsed, the investigations did see both Ajit Patel and Kirti Patel step down from the firm's Board in order to fight allegations levelled at them; Kirti Patel now occupies the position of Group Executive Director in the company. Perhaps ironically, given the legal battles the firm has faced, Goldshield's current Non Executive Chairman is Dr Keith Hellawell, who in previous years was a Chief Constable for two British police forces and in the late 90s was responsible for the UK's anti-drugs policy. For its most recent fiscal year, ended March 2009, Goldshield reported revenues worth £98.4 million (US$156.9 million), with profit after tax of £13.9 million (US$22.1 million). This was a significant improvement on the revenues of £84.9 million and profit after tax of £6.3 million reported for the previous fiscal year.
Ajit Patel is now involved in one of the parties bidding to acquire Goldshield, AIT Investments, which was the first to announce an offer. AIT describes itself as a newly-incorporated company formed by the Fuhrer family for the purpose of implementing the acquisition of Goldshield. The Fuhrers are an Israeli family which own and control the Neopharm group of companies, which market ethical pharmaceuticals and branded consumer healthcare products.
The other bidder for Goldshield is Midas Bidco, an investment vehicle set up by Goldshield's management team; involved in this bid is Goldshield co-founder, Kirti Patel; the two brothers are thus facing off over control of the company they set up and then had to withdraw from in order to fight the price fixing allegations.
AIT commenced bidding for Goldshield with an offer of 440 pence per share, valuing the company at some £162.1 million (US$257.1 million). In response, Midas announced it had put financial backing in place to allow it to make an offer above 440 pence per share. AIT hit back, raising its offer to 450 pence per share, valuing the company at £165.7 million (US$262.8 million). Bidco then upped its offer to 460 pence per share, making the firm worth £169 million (US$268.0 million). In the latest turn, AIT then increased its bid on 2nd October to 480 pence per share, which would value Goldshield at £176.8 million (US$280.4 million). At the time of writing, this is where the bidding rests. However, there is no doubt that the deal, which has pitched two brothers against each other, is not yet done.
Ian Platts - Editor, World Generic Markets
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