Roche shares knocked by concern over side effects in obesity pill trial
Roche shares fall 3.5%
Early study trial showed high rate of temporary side effects
JP Morgan analysts say heart rate increase is as a concern
Roche plans slower ramp-up of pill dose in next trial
Updates share price in paragraph 2, further details on side effects in pill trial in paragraphs 6 and 8
FRANKFURT, Sept 12 (Reuters) -Shares in Roche ROG.S dropped to a two-month low on Thursday after an experimental weight-loss pill that carries high market hopes was linked to an elevated rate of temporary side effects in its initial test phase on humans.
Roche shares were trading 3.5% down by 0940 GMT, the second biggest faller on the pan-European STOXX 600 index .STOXX, after the company presented details on the trial with once-daily pill CT-996 late on Wednesday.
A brief summary in July of the study's promising results had boosted the Swiss drugmaker's share price.
According to a presentation at a meeting of the European Association for the Study of Diabetes in Madrid, all 25 trial participants experienced mild or moderate side effects, or adverse events in industry parlance, including those that only received an ineffective placebo.
Side effects from the pill, part of Roche's $2.7 billion acquisition of Carmot in December, were mostly gastrointestinal (GI), like those associated with similar drugs.
However, it also disclosed a higher heart rate by up to 15 beats per minute, which Roche said was in line with other drugs in the class. Still, JP Morgan analysts said this was a concern because any impact on heart health would become a key differentiator in a competitive market.
The analysts, and their counterparts at Barclays and Jefferies, described the overall number of adverse events as high.
Side effects data that Roche released on Monday on another early Carmot project, injection CT-388, had also weighed on its shares, for a 5.4% decline so far this week.
"Investor excitement for Roche's obesity franchise may now take a pause, in our view, given both acquired assets showed higher-than-anticipated GI side effects," Jefferies analysts said.
SECOND TRIAL PHASE TO START NEXT YEAR
In terms of efficacy, Roche reiterated its statement in July that the once-daily pill CT-996 resulted in a placebo-adjusted average weight loss of 6.1% within four weeks in obese patients without diabetes.
It said the Phase I trial had followed a convention of ramping up the drug dose, a process known as titration, faster than is planned for later trial stages, in order to quickly uncover any unforeseen side effects.
The frequency of adverse events was "consistent with brisk up-titration and early stage of development", Roche said.
"These data support the continued investigation of CT-996 in studies of longer duration with larger sample sizes and slower titrations," the company said, adding that the second of three trial stages would start next year.
But JP Morgan analysts cautioned that a slower-ramp up in larger trials could make it impossible to replicate the fast weight loss that had impressed markets in July.
"The concerning tolerability profile... may be hard to titrate away without a significant decline in efficacy," they said in a note.
An update on Wednesday by Novo Nordisk NOVOb.CO, a pioneer in the weight-loss market alongside Eli Lilly, saying that its experimental pill was associated with mild-to-moderate side effects, was more favourably received by investors.
Roche also said on Wednesday that the headline result of 6.1% weight loss over four weeks was based on just six patients, underscoring the uncertainty of the development project.
Reporting by Ludwig Burger, editing by Rachel More and Emelia Sithole-Matarise
면책조항: XM Group 회사는 체결 전용 서비스와 온라인 거래 플랫폼에 대한 접근을 제공하여, 개인이 웹사이트에서 또는 웹사이트를 통해 이용 가능한 콘텐츠를 보거나 사용할 수 있도록 허용합니다. 이에 대해 변경하거나 확장할 의도는 없습니다. 이러한 접근 및 사용에는 다음 사항이 항상 적용됩니다: (i) 이용 약관, (ii) 위험 경고, (iii) 완전 면책조항. 따라서, 이러한 콘텐츠는 일반적인 정보에 불과합니다. 특히, 온라인 거래 플랫폼의 콘텐츠는 금융 시장에서의 거래에 대한 권유나 제안이 아닙니다. 금융 시장에서의 거래는 자본에 상당한 위험을 수반합니다.
온라인 거래 플랫폼에 공개된 모든 자료는 교육/정보 목적으로만 제공되며, 금융, 투자세 또는 거래 조언 및 권고, 거래 가격 기록, 금융 상품 또는 원치 않는 금융 프로모션의 거래 제안 또는 권유를 포함하지 않으며, 포함해서도 안됩니다.
이 웹사이트에 포함된 모든 의견, 뉴스, 리서치, 분석, 가격, 기타 정보 또는 제3자 사이트에 대한 링크와 같이 XM이 준비하는 콘텐츠 뿐만 아니라, 제3자 콘텐츠는 일반 시장 논평으로서 "현재" 기준으로 제공되며, 투자 조언으로 여겨지지 않습니다. 모든 콘텐츠가 투자 리서치로 해석되는 경우, 투자 리서치의 독립성을 촉진하기 위해 고안된 법적 요건에 따라 콘텐츠가 의도되지 않았으며, 준비되지 않았다는 점을 인지하고 동의해야 합니다. 따라서, 관련 법률 및 규정에 따른 마케팅 커뮤니케이션이라고 간주됩니다. 여기에서 접근할 수 있는 앞서 언급한 정보에 대한 비독립 투자 리서치 및 위험 경고 알림을 읽고, 이해하시기 바랍니다.
