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DENISE ROLAND
Aug. 28, 2016 2:40 p.m. ET
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GlaxoSmithKline PLC is pinning the future of its HIV business on an audacious bet: upending the decades-old treatment strategy that has turned a fatal illness into a chronic condition.
The treatment of HIV, the virus that causes AIDS, has changed little since the mid-1990s, when the introduction of a new class of drug dramatically improved HIV therapy. Doctors found that combining the newer type of antiretroviral drug with two drugs from an earlier class hindered the virus from developing resistance.
A three-drug regimen has remained the standard approach since then, with drug development efforts focused on making ever more powerful triple combinations.
Glaxo executives want to change that. They hope the U.K.-based drug company’s latest HIV pill is powerful enough to suppress the virus with the help of just one other drug. That, according to Chief Executive Andrew Witty, would be a “game-changer,” because taking fewer drugs would produce fewer side effects.
Now, Glaxo’s majority-owned HIV business ViiV Healthcare, in which Pfizer Inc. of the U.S. and Shionogi & Co. of Japan hold minority stakes, is getting down to the long process of proving it.
The drug in question, dolutegravir, is one of a class of HIV drugs known as integrase inhibitors that rapidly reduce the level of virus in the blood. It is already approved for use as part of traditional triple therapy and so far, there are no reported cases of the virus developing resistance to dolutegravir in patients who are new to treatment. That makes it unique among integrase inhibitors, according to David Hardy, an HIV doctor and a spokesman for the HIV Medicines Association, an advocacy group.
While dolutegravir’s profile suggests it could potentially suppress HIV without the help of any other drug, Glaxo is taking a precautionary stepwise approach to investigating its promise, said a company spokeswoman.
The most important benefit of a two-drug regimen is that it would come with fewer side effects. Such effects, including nausea, diarrhea, kidney problems and bone-thinning, are one of the most common reasons for patients to change an HIV regimen. It could also lighten the financial burden of HIV.
Rochelle Walensky, associate professor of medicine at Harvard Medical School, estimated that switching just a quarter of patients currently on triple therapy to dolutegravir plus 3TC—an older, generic HIV drug—would knock more than $3 billion off the cost of treating HIV over a five-year period. The cost saving is less clear if both drugs in the regimen are still under patent protection.
Glaxo is putting “tremendous focus and priority” on the development of two-drug regimens, Mr. Witty said. According to analysis by UBS, the opportunity is significant: If dual therapy becomes the strategy that doctors prefer, Glaxo could grab a much bigger slice of the market and overtake Gilead Sciences Inc. to become the biggest player in HIV treatment within three years.
Over the past year, Glaxo has started several large clinical trials that aim to show that combining dolutegravir with just one other HIV medicine works as well as traditional triple therapy at suppressing the virus.
In one set of trials, it is testing dolutegravir alongside rilpivirine, a brand-name HIV drug made by Johnson & Johnson unit Janssen Pharmaceuticals. In another, it is combining dolutegravir with 3TC, the generic drug used in Dr. Walensky’s analysis.
It also plans to start a late-stage trial combining an injectable version of dolutegravir with rilpivirine. An earlier trial showed this combination was as effective as a three-drug regimen when the virus had already been suppressed by an initial period of triple therapy.
The trials won’t start yielding results until next year, but a small study led by Pedro Cahn,a doctor in Argentina, offers some reason for optimism. In that 48-week trial, dolutegravir plus 3TC suppressed HIV levels in 18 out of 20 previously untreated patients.
Even if Glaxo’s large clinical trials succeed, it could face another challenge: inertia.
In the past year, Gilead has launched a series of triple therapies using a new HIV drug called TAF that can be administered at a much lower dose than its predecessor, causing less harm to the kidneys.
Christoph Wyen, an HIV specialist at the University Hospital Cologne in Germany, said the advent of these less-toxic triple therapies reduces the incentive for doctors to switch patients to simpler regimens. He said dual therapy might take off more quickly in older patients, who are more likely to have age-related health complications.
Gilead and Glaxo both have strong positions in the HIV market with TAF- and dolutegravir-based triple regimens, respectively. But Gilead is developing a new integrase inhibitor that, if proven equal to dolutegravir, could give it an important advantage in the triple-therapy market.
The worst-case scenario for Glaxo would be for its dual therapies to fail and for Gilead’s integrase inhibitor—which, if successful, is expected to launch in 2018—to steal market share from dolutegravir. That could send Glaxo’s HIV business into decline after 2018, according to UBS, though Mr. Witty says that the downside is limited because dolutegravir will be well-established by the time Gilead’s competitor comes along.
“It’s not a foregone conclusion that [dual therapy] is going to work,” said Dr. Hardy. But “I’ve watched the development of dolutegravir enough to understand why they are trying to do this.”
Write to Denise Roland at Denise.Roland@wsj.com
GlaxoSmithKline PLC, imechukua biashara ya HIV kwa kujiamini, hii ni kutokana na tiba iliyopo ambayo ilipata mabadiliko makubwa katika mikaka kumi iliyopita; mabadiliko hayo alipelekea ugonjwa uliokuwa unauwa kuwa gonjwa sugu.
Matibaby ya virusi vya HIV ambao wanasababish AIDS, yamebadilika kidogo kutoka miaka ya 1990 ambapo dawa mpya ghafla ziliboresha afya ya wagonjwa. Madaktari waligundua kuwa kuchanganya aina mpya ya dawa ya antiretoviral (ARV) na dawa nyingine mbili ya dawa, kuliweza kuzuia vurusi kuwa sugu na matibabu.
Mfumo huo wa dawa tatu umebaki kuwa ndiyo mfumo wa tiba ya kawaida kutoka hapo, kutokana na maendeleo ya dawa, jitihada zilianza kuangalia mchanganyo wa dawa tatu wenye nguvu zaidi.
Maafisa wa juu wa Glaxo wanataka kubadilisha tiba hiyo. Tumaini la kampuni hiyo ya madawa iliyoko Uingereza imetoa dawa mpya ambayo inanguvu ya kumaliza virus vilivyopo kwenye damu kwa kusaidiwa na dawa moja nyingine. Kutokana na maelezo ya Mtendaji mkuu wa kampuni hiyo Andrew Witty, "hatua hii ni kubadilisha mchezo" kwasababu kunywa dawa chache kunamaanisha madhara machache zaidi ya dawa kwenye mwili.
Kwa sasa Glaxo mbayo ni mmiliki mkuu wa ViiV Healthcare, ambapo Pfzer Inc ya Marekani na Shionoga & Co ya Japan wana hisa ndogo, imeanza mlolongo wa safari ya kutengeneza dawa hiyo.
Dawa hiyo inayoongelewa dolutegravir, ni moja ya dawa za HIV inayojulikana kama integrase inhibitors ambayo kwa haraka inamaliza kiwango cha virusi walioko kwenye damu. Imeshaanza kutumika maka sehemu ya tiba ya awali ya dawa tatu na hakuna kesi yeyote iliyoripotiwa ya virusi kuwa sugu kutokana na tiba ya dolutegravi kwa wagonjwa wapya.
Hii imefanya dawa hii kuwa ya kipekee kati ya integrase inhibitors, hii imeelezwa na David Hardy, daktari wa HIV na msemaji wa HIV Medicine Association.
Wakati maelezo ya dolutegravir yanaonyesha kuwa dawa hiyo inauwezo wa kutokomeza HIVkwenye damu bila msaada wa dawa nyingine yeyote ,Glaxo inachukua tahadhari katika hatua hii wakati uchunguzi ukiendelea kama ilivyoelezwa na msemaji wa kampuni.
Mafanikio makubwa ya dawa mbili yakuwa ni pamoja na madhara machache kwenye mwili, madhara kama moyo kuchefuka, kuharisha, matatizo ya figo na mifupa kuwa myembamba ambayo mara nyingi yanapelekea wagonjwa kubadilishiwa dawa. Pia itapunguza gharama katika tiba ya HIV.
Rochelle Welansky, ambae ni professor mshirikii wa madawa katika chuokikuu cha tiba cha Havard, amekadiria kuwa, kwa kubadilisha dawa kwa robo tu ya wagonjwa ambao wako katika tiba ya dawa tatu kwa sasa, kutaokoa US$ 3 billion katika matibabu ya HIV kwa miaka 5. Uokoaji huo wa pesa haujawekwa wazi kwakuwa dawa ya dolutegravir bado inalindwa kisheria.
Glaxo inachukua hatua kubwa katika umuhimu wa kutengeneza mfumo wa dawa mbili na ambao madaktari wanaupendelea, Glaxo inaweza kukamata kipande kikubwa katika soko ambalo kwa sasa limishikiliwa na na Gilead Sciences Inc. na Glaxo wakinanikiwa wakatakuwa wachezaji wakubwa katika matibabu ya HIV katika kipindi cha miaka mitatu ijayo.
Katika mwaka uliopita, Glaxo wameanza majaribio mbalimbali ya kuchanganya dolutegravir na dawa nyingine moja ya HIV na inafanya kazi vizuri to kama ilivyo katika tiba ya dawa tatu.
Katika jaribio moja iljaribiwa dolutegravir pamoja na rilpivirine, jina la dawa iliyotengenezwa na Johnson & Johnson katika kupitia kampuni yao ya Janseen Pharmaceuticals, katika jaribio lingine dolutegravir ilichanywa na 3TC, ambayo ni moja ya dawa za HIV na ilitumiwa na Dr. Walensky.
Glaxo katika siku za mbeleni inampango wa kutumia dawa za sindano za dolutegarvir na rilpivirne katika jaribio la awali lilionyesha kuwa mchanganyiko huo unaweka kufanya kazi kama ilivyokuwa katika dawa tatu wakati mgonjwa akiwa na undictable status.
Hata kama jaribio kubwa la Glaxo likifanikiwa inaweza bado kuwa kwenye mapambano; kwa matendo.
Katika mwaka uliopita, Gilead wameanzisha mfumo wa dawa tatu wakitumia dawa ya HIV iitwayo TAF, ambayo mgonjwa anapewa katika dozi ndogo kuliko zilizotangulia na madhara yake ni machache katika figo.
Christoph Wyen, ambae in mtaalam wa HIV katika chuo kikuu cha Cologne Ujerumani, alisema kuwa uzuri wa dawa hizi zenye uchache wa makali, zinasaidia madaktari kutobadilisha dawa kwa wagonjwa. Alisema dawa mbili zitawasaidia kwa haraka wazee na watuwazima ambao wako kwenye hatari ya kushambuliwa pia na magonjwa yanayosababishwa na umri.
Kampuni zote mbili Glaxo na Gilead ziko katika nafasi yenye nguvu katika soko la HIV, pamoja na TAF na dolutegravir, na mfumo wa dawa ya integrase inhibitor ambayo imeshadhihirisha kuwa na uwezo sawa na dolutegravir, hii inaweza kuipa Gilead nafasi ya mbele na muhimu zaidi katika soko la dawa hii.
DENISE ROLAND
Aug. 28, 2016 2:40 p.m. ET
0 COMMENTS
GlaxoSmithKline PLC is pinning the future of its HIV business on an audacious bet: upending the decades-old treatment strategy that has turned a fatal illness into a chronic condition.
The treatment of HIV, the virus that causes AIDS, has changed little since the mid-1990s, when the introduction of a new class of drug dramatically improved HIV therapy. Doctors found that combining the newer type of antiretroviral drug with two drugs from an earlier class hindered the virus from developing resistance.
A three-drug regimen has remained the standard approach since then, with drug development efforts focused on making ever more powerful triple combinations.
Glaxo executives want to change that. They hope the U.K.-based drug company’s latest HIV pill is powerful enough to suppress the virus with the help of just one other drug. That, according to Chief Executive Andrew Witty, would be a “game-changer,” because taking fewer drugs would produce fewer side effects.
Now, Glaxo’s majority-owned HIV business ViiV Healthcare, in which Pfizer Inc. of the U.S. and Shionogi & Co. of Japan hold minority stakes, is getting down to the long process of proving it.
The drug in question, dolutegravir, is one of a class of HIV drugs known as integrase inhibitors that rapidly reduce the level of virus in the blood. It is already approved for use as part of traditional triple therapy and so far, there are no reported cases of the virus developing resistance to dolutegravir in patients who are new to treatment. That makes it unique among integrase inhibitors, according to David Hardy, an HIV doctor and a spokesman for the HIV Medicines Association, an advocacy group.
While dolutegravir’s profile suggests it could potentially suppress HIV without the help of any other drug, Glaxo is taking a precautionary stepwise approach to investigating its promise, said a company spokeswoman.
The most important benefit of a two-drug regimen is that it would come with fewer side effects. Such effects, including nausea, diarrhea, kidney problems and bone-thinning, are one of the most common reasons for patients to change an HIV regimen. It could also lighten the financial burden of HIV.
Rochelle Walensky, associate professor of medicine at Harvard Medical School, estimated that switching just a quarter of patients currently on triple therapy to dolutegravir plus 3TC—an older, generic HIV drug—would knock more than $3 billion off the cost of treating HIV over a five-year period. The cost saving is less clear if both drugs in the regimen are still under patent protection.
Glaxo is putting “tremendous focus and priority” on the development of two-drug regimens, Mr. Witty said. According to analysis by UBS, the opportunity is significant: If dual therapy becomes the strategy that doctors prefer, Glaxo could grab a much bigger slice of the market and overtake Gilead Sciences Inc. to become the biggest player in HIV treatment within three years.
Over the past year, Glaxo has started several large clinical trials that aim to show that combining dolutegravir with just one other HIV medicine works as well as traditional triple therapy at suppressing the virus.
In one set of trials, it is testing dolutegravir alongside rilpivirine, a brand-name HIV drug made by Johnson & Johnson unit Janssen Pharmaceuticals. In another, it is combining dolutegravir with 3TC, the generic drug used in Dr. Walensky’s analysis.
It also plans to start a late-stage trial combining an injectable version of dolutegravir with rilpivirine. An earlier trial showed this combination was as effective as a three-drug regimen when the virus had already been suppressed by an initial period of triple therapy.
The trials won’t start yielding results until next year, but a small study led by Pedro Cahn,a doctor in Argentina, offers some reason for optimism. In that 48-week trial, dolutegravir plus 3TC suppressed HIV levels in 18 out of 20 previously untreated patients.
Even if Glaxo’s large clinical trials succeed, it could face another challenge: inertia.
In the past year, Gilead has launched a series of triple therapies using a new HIV drug called TAF that can be administered at a much lower dose than its predecessor, causing less harm to the kidneys.
Christoph Wyen, an HIV specialist at the University Hospital Cologne in Germany, said the advent of these less-toxic triple therapies reduces the incentive for doctors to switch patients to simpler regimens. He said dual therapy might take off more quickly in older patients, who are more likely to have age-related health complications.
Gilead and Glaxo both have strong positions in the HIV market with TAF- and dolutegravir-based triple regimens, respectively. But Gilead is developing a new integrase inhibitor that, if proven equal to dolutegravir, could give it an important advantage in the triple-therapy market.
The worst-case scenario for Glaxo would be for its dual therapies to fail and for Gilead’s integrase inhibitor—which, if successful, is expected to launch in 2018—to steal market share from dolutegravir. That could send Glaxo’s HIV business into decline after 2018, according to UBS, though Mr. Witty says that the downside is limited because dolutegravir will be well-established by the time Gilead’s competitor comes along.
“It’s not a foregone conclusion that [dual therapy] is going to work,” said Dr. Hardy. But “I’ve watched the development of dolutegravir enough to understand why they are trying to do this.”
Write to Denise Roland at Denise.Roland@wsj.com
GlaxoSmithKline PLC, imechukua biashara ya HIV kwa kujiamini, hii ni kutokana na tiba iliyopo ambayo ilipata mabadiliko makubwa katika mikaka kumi iliyopita; mabadiliko hayo alipelekea ugonjwa uliokuwa unauwa kuwa gonjwa sugu.
Matibaby ya virusi vya HIV ambao wanasababish AIDS, yamebadilika kidogo kutoka miaka ya 1990 ambapo dawa mpya ghafla ziliboresha afya ya wagonjwa. Madaktari waligundua kuwa kuchanganya aina mpya ya dawa ya antiretoviral (ARV) na dawa nyingine mbili ya dawa, kuliweza kuzuia vurusi kuwa sugu na matibabu.
Mfumo huo wa dawa tatu umebaki kuwa ndiyo mfumo wa tiba ya kawaida kutoka hapo, kutokana na maendeleo ya dawa, jitihada zilianza kuangalia mchanganyo wa dawa tatu wenye nguvu zaidi.
Maafisa wa juu wa Glaxo wanataka kubadilisha tiba hiyo. Tumaini la kampuni hiyo ya madawa iliyoko Uingereza imetoa dawa mpya ambayo inanguvu ya kumaliza virus vilivyopo kwenye damu kwa kusaidiwa na dawa moja nyingine. Kutokana na maelezo ya Mtendaji mkuu wa kampuni hiyo Andrew Witty, "hatua hii ni kubadilisha mchezo" kwasababu kunywa dawa chache kunamaanisha madhara machache zaidi ya dawa kwenye mwili.
Kwa sasa Glaxo mbayo ni mmiliki mkuu wa ViiV Healthcare, ambapo Pfzer Inc ya Marekani na Shionoga & Co ya Japan wana hisa ndogo, imeanza mlolongo wa safari ya kutengeneza dawa hiyo.
Dawa hiyo inayoongelewa dolutegravir, ni moja ya dawa za HIV inayojulikana kama integrase inhibitors ambayo kwa haraka inamaliza kiwango cha virusi walioko kwenye damu. Imeshaanza kutumika maka sehemu ya tiba ya awali ya dawa tatu na hakuna kesi yeyote iliyoripotiwa ya virusi kuwa sugu kutokana na tiba ya dolutegravi kwa wagonjwa wapya.
Hii imefanya dawa hii kuwa ya kipekee kati ya integrase inhibitors, hii imeelezwa na David Hardy, daktari wa HIV na msemaji wa HIV Medicine Association.
Wakati maelezo ya dolutegravir yanaonyesha kuwa dawa hiyo inauwezo wa kutokomeza HIVkwenye damu bila msaada wa dawa nyingine yeyote ,Glaxo inachukua tahadhari katika hatua hii wakati uchunguzi ukiendelea kama ilivyoelezwa na msemaji wa kampuni.
Mafanikio makubwa ya dawa mbili yakuwa ni pamoja na madhara machache kwenye mwili, madhara kama moyo kuchefuka, kuharisha, matatizo ya figo na mifupa kuwa myembamba ambayo mara nyingi yanapelekea wagonjwa kubadilishiwa dawa. Pia itapunguza gharama katika tiba ya HIV.
Rochelle Welansky, ambae ni professor mshirikii wa madawa katika chuokikuu cha tiba cha Havard, amekadiria kuwa, kwa kubadilisha dawa kwa robo tu ya wagonjwa ambao wako katika tiba ya dawa tatu kwa sasa, kutaokoa US$ 3 billion katika matibabu ya HIV kwa miaka 5. Uokoaji huo wa pesa haujawekwa wazi kwakuwa dawa ya dolutegravir bado inalindwa kisheria.
Glaxo inachukua hatua kubwa katika umuhimu wa kutengeneza mfumo wa dawa mbili na ambao madaktari wanaupendelea, Glaxo inaweza kukamata kipande kikubwa katika soko ambalo kwa sasa limishikiliwa na na Gilead Sciences Inc. na Glaxo wakinanikiwa wakatakuwa wachezaji wakubwa katika matibabu ya HIV katika kipindi cha miaka mitatu ijayo.
Katika mwaka uliopita, Glaxo wameanza majaribio mbalimbali ya kuchanganya dolutegravir na dawa nyingine moja ya HIV na inafanya kazi vizuri to kama ilivyo katika tiba ya dawa tatu.
Katika jaribio moja iljaribiwa dolutegravir pamoja na rilpivirine, jina la dawa iliyotengenezwa na Johnson & Johnson katika kupitia kampuni yao ya Janseen Pharmaceuticals, katika jaribio lingine dolutegravir ilichanywa na 3TC, ambayo ni moja ya dawa za HIV na ilitumiwa na Dr. Walensky.
Glaxo katika siku za mbeleni inampango wa kutumia dawa za sindano za dolutegarvir na rilpivirne katika jaribio la awali lilionyesha kuwa mchanganyiko huo unaweka kufanya kazi kama ilivyokuwa katika dawa tatu wakati mgonjwa akiwa na undictable status.
Hata kama jaribio kubwa la Glaxo likifanikiwa inaweza bado kuwa kwenye mapambano; kwa matendo.
Katika mwaka uliopita, Gilead wameanzisha mfumo wa dawa tatu wakitumia dawa ya HIV iitwayo TAF, ambayo mgonjwa anapewa katika dozi ndogo kuliko zilizotangulia na madhara yake ni machache katika figo.
Christoph Wyen, ambae in mtaalam wa HIV katika chuo kikuu cha Cologne Ujerumani, alisema kuwa uzuri wa dawa hizi zenye uchache wa makali, zinasaidia madaktari kutobadilisha dawa kwa wagonjwa. Alisema dawa mbili zitawasaidia kwa haraka wazee na watuwazima ambao wako kwenye hatari ya kushambuliwa pia na magonjwa yanayosababishwa na umri.
Kampuni zote mbili Glaxo na Gilead ziko katika nafasi yenye nguvu katika soko la HIV, pamoja na TAF na dolutegravir, na mfumo wa dawa ya integrase inhibitor ambayo imeshadhihirisha kuwa na uwezo sawa na dolutegravir, hii inaweza kuipa Gilead nafasi ya mbele na muhimu zaidi katika soko la dawa hii.
