FDA approves new AIDS drug
WRITTEN BY: Stanley Jackson
The struggle towards a ‘cure for AIDS’ has, for a long time, been considered one of the Holy Grails of medical advancement. Although a definitive cure remains a long way off, a breakthrough, being billed as one of the biggest scientific advancements in the study of AIDS for thirty years, took place this July.
Emtricitabine/tenofovir disoproxil fumarate (or Truvada for those of us who prefer to speak in fewer than forty syllables) has been tested under strenuous conditions by the FDA, and has turned up some impressive results.
The trial, conducted on 4,758 heterosexual couples where one partner was HIV-infected and the other was not, showed that Truvada reduced the risk of becoming infected by 75 percent compared with those who took a placebo.
The FDA is a notoriously hard agency to gain accreditation from; with the cost and time required to get from initial clinical trials to simply submitting a drug for FDA approval averaging $125 million and between 6-11 years.
"Today’s approval marks an important milestone in our fight against HIV," said FDA Commissioner Margaret A. Hamburg, M.D. "Every year, about 50,000 US adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."
What will prove beneficial for the United States, however, may reveal a chronic issue with world healthcare. Countries like Botswana and South Africa, each with AIDS rates of 20 percent or more amongst 16 -49 year olds, will not be able to distribute the drug to those who most need it, due to its high cost.
Unfortunately, the supply of Truvada is limited, meaning that celebrations regarding the drugs’ potential effectiveness will be marred by concerns of how to best allocate those resources.
“When I get to the question of who pays for this, I am completely dumbfounded”, said Kevin Frost, chief executive of The Foundation of Aids Research.
It must be an ethical concern for all involved that many countries, particularly those in Africa, do not have the capacity to treat those already infected, let alone prevent against the disease in pill form.
The risk is that the new drug will not reach those which so desperately needs it, but instead will simply reduce the amount of AIDS sufferers in countries with already low rates of infection. The dream of a ‘cure’ for AIDS may not reside within the scientific or medical discoveries themselves, but in the development of a plan for widespread transference of healthcare in a true global sense.
Bachem turns 50 - a timeline
Bachem, a supplier to pharmaceutical and biotechnology companies worldwide, is celebrating its 50th anniversary this month. We take a look at the Swiss company's history.
1971 - beginnings
Bachem is founded by entrepreneur Peter Grogg in Liestal, a small town near Basel in Switzerland. Grogg started the firm with just two employees, and with a focus on peptide synthesis - peptides are composed of amino acids that have a variety of functions treating health conditions such as cancer and diabetes.
1977 - 1981 - early growth
Bachem moves its headquarters to the Swiss town of Bubendorf, with eight employees. In 1978 the company produces peptides for use in medicines for the first time. In 1981 production capacity triples and the workforce grows to 150.
1987 - 1996 - worldwide expansion
The company expands into the US with Bachem Bioscience, Inc. in Philadelphia. To strengthen its presence in Europe, Bachem opens sales and marketing centres in Germany in 1988.
Further sales centres open in France in 1993. By 1995 the company employs 190 people. In 1996 it acquires the second largest manufacturer of peptides in the world and forms Bachem California with a site in Torrance.
1998 - 2003 - Bachem goes public
Bachem company goes public and lists shares on the Swiss Stock Exchange. Further acquisitions include Peninsula Laboratories, Inc, based in California, and Sochinaz SA, a Swiss-based manufacturer of active pharmaceutical ingredients. By 2001, the company has 500 employees and sales reach 141 million CHF.
In 2003 the organisation is given a new legal holding structure to support its continued growth, which remains in place to this day.
2007 - 2013 - acquisitions
Bachem acquires a brand by Merck Biosciences for ready-to-use clinical trial materials and related services.
In 2013, together with GlyTech, Inc. Bachem announces the development of a new amino acid that can help to treat multiple sclerosis, with a world market of more than $4 billion.
In 2015 it acquires the American Peptide Company (APC), which becomes integrated into Bachem Americas.
2016 - 2019 - a global leader
In 2016 the group opens a new building dedicated to R&D projects and small series production in Bubendorf. With a total of 1,022 employees, the workforce exceeds the 1,000 mark for the first time in the company’s history. Sales are over the 200 million mark for the first time at 236.5 million CHF.
Bachem expands into Asia with the establishment of a new company in Tokyo called Bachem Japan K.K.
By 2019 Bachem has a growing oligonucleotide portfolio - these are DNA molecules used in genetic testing, research, and forensics. It is hoped this will become a significant product range in the future.
2020 - COVID-19
Despite the COVID-19 pandemic, Bachem secures its supply of active ingredients, and even increases it in critical areas. Sales exceed the 400 million Swiss franc mark for the first time, and 272 new employees are hired.
2021 - a milestone anniversary
Bachem celebrates its 50th anniversary and position as a global leader in the manufacture of peptides. While it remains headquartered in Bubendorf, the company employs 1,500 people at six locations worldwide. In the next five years there are plans to continue expanding.
Commemorating the company's anniversary, Kuno Sommer, Chairman of the Board of Directors, said: "Bachem's exceptional success story from a small laboratory to a global market leader is closely linked to Peter Grogg's values, and has been shaped by innovation, consistent quality and cost awareness, as well as by entrepreneurial vision."