V iroMed

http://www.dailian.co.kr/news/view/811128/

http://biospectator.com/view/news_view.php?varAtcId=8012

15일 국가항암신약개발사업단이 최근 시장조사기관인 글로벌데이터(Globaldata) 자료를 분석한 결과에 따르면 키트루다는 2021년 137억달러(16조1500억원)의 매출을 기록해 셀진의 다발성 골수종 치료제 레블리미드(135억달러)를 앞서게 된다. 이후 성장세를 지속해 2023년에는 167억달러 매출을 올릴 것으로 예상됐다.

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신약 매출 규모 1년에 20조 ... 

헬릭스미스도 신약 1개 ..1년 매출 ...미국에서만 10조 달성할 날을 기다려 봅니다. 

http://biospectator.com/view/news_view.php?varAtcId=7914

미국 바이오 기업들의 인수 금액은 정말 대단하군요. 대한민국에서도 이런 메가딜이 향후 나오기를 기대해 봅니다. 

https://www.fiercepharma.com/special-report/top-20-drugs-by-2018-u-s-sales

Pfizer Lyrica가 약 $ 3.59 Billion 미국에서 판매되었네요.. 

VM-202 DPN은 이것 이상 달성하는 것 어려워 보이지 않습니다. 약효 좋고..부작용 없고... 

https://www.fiercepharma.com/pharma/pfizer-never-say-never-m-a-buys-oncology-innovator-array-for-11-4b

12조 이상 큰 인수건이 또 나왔네요.. 

바이오가 대세이긴 대세입니다. 

Array는 오늘만 56% 상승...^_^

http://m.medipana.com/news_viewer.asp?NewsNum=240961&MainKind=C&NewsKind=67&vCount=12&vKind=1&Page=1&sWord=&Qstring=sWord%3D%26sDate%3D

주변에 당뇨병 환자분들 많고, 당뇨병 신약 개발하는 회사들도 많습니다. 

이번 기회에 당뇨병에 대해서 이해하시고 가세요. 

https://seekingalpha.com/article/4254073-bluebird-bios-chmp-response-lays-ground-work-first-gene-therapy-approval

http://m.medipana.com/news_viewer.asp?NewsNum=237415&MainKind=A&NewsKind=5&vCount=4&vKind=1

믿어도 되나요 ? 

https://www.fiercepharma.com/special-report/top-15-pharma-companies-by-2018-revenue

https://www.fiercepharma.com/pharma/europe-sets-up-first-bluebird-gene-therapy-approval-thumbs-up-thalassemia-treatment

약 가격이 20억 ^_^...   Bluebird bio의 성공으로 바이로메드의 성공도 눈 앞에 다가 온 것 같네요..

luebird Bio’s development of a gene therapy to treat transfusion-dependent β-thalassemia (TDT) has been far from easy, but the final path to market is finally coming into view for the 27-year-old company.

On Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion (PDF) on the product, Zynteglo (formerly LentiGlobin), setting up a likely approval from the European Commission during the second quarter. The European Commission generally follows the CHMP’s recommendations.

Zynteglo is designed to add functional copies of an altered form of the β-globin gene into TDT patients’ own blood stem cells. The inserted genes then produce hemoglobin at normal levels, reducing or eliminating the need for the frequent blood transfusions that TDT patients generally receive. The positive CHMP decision “is a crucial step toward providing what would be the first one-time gene therapy for people living with TDT,” said David Davidson, M.D., Bluebird’s chief medical officer, in a statement.

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If Zynteglo is given the green light in the EU in the second quarter as predicted, it will be Bluebird’s first marketed product—and a major achievement in a multiyear development program marked by a fair share of disappointments.

In 2015, data from an early trial of the product showed wide variations in responses, which raised questions about whether the gene therapy was really that effective. So the company changed the manufacturing process, as well as the protocol for preparing patients for the therapy.

RELATED: Bluebird preps E.U. filing for revamped thalassemia gene therapy

The value of those changes showed last summer, when Bluebird presented data from a phase 1/2 trial of Zynteglo at the European Hematology Association conference. The data showed that the therapy cuts the sickling of red blood cells—a hallmark of TDT—by 30% to 60%, which Bluebird considered to be above the threshold of a clinically significant response.

Bluebird has told investors to expect it will file for FDA approval of Zynteglo by the end of this year. It hasn’t announced pricing for either the U.S. or Europe yet, but the company has suggested that the “intrinsic value” of the product is $2.1 million.

At the J.P. Morgan Healthcare Conference in January, Bluebird said it is developing a reimbursement model for the gene therapy that might include an upfront fee and installment payments spread over five years.

RELATED: Bluebird opens manufacturing facility as it moves gene therapies forward

No doubt pricing will be a matter of intense focus as Bluebird moves closer to becoming a commercial-stage biotech. But Wall Street analysts are clearly expecting the company to find pricing solutions that will drive its growth without alienating insurance companies, not to mention U.S. legislators who are fixated on high drug prices.

Analysts at Jefferies estimate that sales of Zynteglo in thalassemia will peak at $696 million in 2026. Bluebird is also testing the product in sickle cell disease, and if it works, sales could hit $1.1 billion in that indication in 2027, Jefferies estimates.

SVB Leerink analyst Mani Foroohar, who issued a note to investors after the CHMP announced its positive opinion, has similar peak sales estimates for Zynteglo. Foroohar noted that Bluebird will be holding an analyst event on May 9, during which it will be expected to provide more details on pricing plans for the product, as well as the “tempo of launch and the rollout of qualified treatment centers in the EU.”

Bluebird has been preparing for a steep growth curve, investing $80 million in its first gene therapy manufacturing facility in Durham, North Carolina. It’s designed to produce clinical supplies of the lentiviral vector that’s a key element of gene and cell therapies, but it will be able to scale up to handle commercial production as soon as a Bluebird product candidates wins approval in the U.S. Bluebird has a European manufacturing agreement with Novasep to produce gene therapies at a site in Gosselies, Belgium.

Several physicians who treat TDT in Europe hailed the positive CHMP decision.

“The present management of TDT, including regular blood transfusions every two to four weeks and daily iron chelation therapy has many psychological and social consequences, including marginalization and isolation,” said Androulla Eleftheriou, executive director of the Thalassaemia International Federation, in the statement from Bluebird.

The potential approval of the gene therapy product, she added, “brings hope that we can dramatically change the course of this disease and the health and quality of lives of patients with TDT.”