Fighting over molecules By Steven Syre Globe Columnist / January 11, 2011
Some fights start over the smallest things. This one is about a molecule called WZ4002.
There is no shortage of people and powerful organizations fighting over the molecule, discovered by Boston scientists at the Dana-Farber Cancer Institute; it could be worth a fortune as a new treatment for many lung cancer patients.
Then again, WZ4002 could turn out to be a big nothing. It’s too early to tell.
But no one is waiting around to find out, and recent lawsuits offer a rare public glimpse of a fight over medicine and money that usually takes place behind closed doors.
Drug giant Novartis International Pharmaceutical Ltd. is locking horns with the scientists who discovered WZ4002. Those researchers are at odds with the president of the company they formed to represent their commercial interests. Dana-Farber is caught awkwardly in the middle, with important interests of its own at stake.
The conflict is remarkable because the molecule is nowhere close to becoming an approved drug. It has not been the subject of a single clinical trial. It’s still a compound in a lab, not a therapy.
John Mirick, a lawyer for researcher Nathanael Gray and three other Dana- Farber scientists behind WZ4002, says development of the molecule has been treading water since the licensing dispute broke out last year.
That would be bad news for patients, the real people at the heart of this story. Jamie Gorenberg has paid close attention to the development of WZ4002 because her mother, Caren Gorenberg, suffers from advanced lung cancer. She recognizes it’s a long shot but hopes the molecule might help her mother in a clinical trial someday soon.
“I know that’s a big if, but we live on ifs,’’ says Gorenberg. “That’s better than nothing, and I’m going to grab onto it.’’
Gorenberg learned about WZ4002 by reading an article in the scientific journal Nature in December 2009 that described how the molecule could help patients with non-small cell lung cancer who also have common gene mutations. Those mutations help the cancer resist the leading treatments, and WZ4002 might get around that problem.
The article in Nature also came as news to executives at Novartis, which spends more than $15 million a year on sponsored research at Dana-Farber, according to court papers. The drug company funded some work in Gray’s lab, and executives soon pressed Dana-Farber for rights to WZ4002. Their view: Novartis owned those commercial rights.
That was a big problem because Dana-Farber gave an option for the rights to Gatekeeper Pharmaceuticals Inc., a company formed by Gray and his colleagues. The cancer institute filed a patent application for WZ4002 but was stuck between the commercial interests of its scientists and a big research sponsor.
Dana-Farber’s solution: Sue and let US District Judge David Woodlock decide who owns what.
“We are not seeking any monetary award,’’ Dana-Farber said in a statement yesterday. “We are simply asking the court to determine which of the two parties has the superior rights to the technology.’’
Meanwhile, the scientists who formed Gatekeeper didn’t see eye to eye with John Chant, whom they hired to run the company and advance the commercial interests of WZ4002.
Chant didn’t like the company’s legal strategy. He made the ambitious argument that Gatekeeper’s founders, who owned 87 percent of the company and constituted its board, were conflicted in the case because they worked at Dana-Farber, among other reasons.
Chant wants to intervene on behalf of Gatekeeper and pursue another legal strategy.
Gray and his colleagues say they are open to a settlement with both Novartis and Dana-Farber. Chant wanted to fight for damages and insisted any settlement must include $750,000 to cover deferred and future compensation for him, according to court papers filed by the scientists.
“The board concluded Mr. Chant was primarily concerned for his salary and benefits,’’ they said in the documents.
Strange fact: Chant is still employed by Gatekeeper.
Chant’s lawyer did not return a call yesterday.
Now the judge has to figure it all out or push for a settlement. But time matters.
“All I can say is, move quickly,’’ Gorenberg says. “I’m not trying to blame anyone or point fingers.’’
The molecule in question may save lives, though the odds are long. But no one will figure that out until everyone agrees on who owns WZ4002.
这种小专利官司，大公司一年没有100个也有20个。重要的是10年后大家依然没有兴趣 做完pre-clinical，tagrisso(osimertinib)都卖了几十亿了吧, 发明人royalty拿到手软了吧。 【 在 lubbock12 (非老非小将) 的大作中提到: 】 : 我这里有个详细的报道，WZ4002很好的药，结果死在诺华制药和Dana Farber 专利之争 : 了，Dana Farber认为这药是我发现的，诺华这药研究我赞助的专利归我。 : Fighting over molecules : By Steven Syre : Globe Columnist / January 11, 2011 : Some fights start over the smallest things. This one is about a molecule : called WZ4002. : There is no shortage of people and powerful organizations fighting over the : molecule, discovered by Boston scientists at the Dana-Farber Cancer : Institute; it could be worth a fortune as a new treatment for many lung : ...................
美国联邦检察官办公室近日宣布，定居南加橙县富乐顿的华裔医生廖学时（Benedict
Liao）在六年期间，以欺诈手段销售未经批准的癌症治疗药物，共牟取超过161万元的
非法收入，他被指控的26项重罪，日前经由陪审团裁定均成立，最高恐面临197年监禁
。该案已订2022年2月14日举行量刑听证会。
81岁的廖学时又名Wada Masao和Masao A. Wada，他面临的26项重罪指控，包括七项电
汇欺诈，11项销售贴错标签的药物，八项销售未经批准的新药，11月2日陪审团裁定这
些控罪都成立。
根据廖学时在为期五天的审判中提供的证据，他经营一家名为Oeyama-Moto的癌症研究
基金会，该基金会在蒙特利公园市（Monterey Park）、西柯汶那市（West Covina）先后设有办事处。
廖学时于2011年和2012年曾向联邦食品暨药物管理局（FDA）提交一份研究新药 (IND) 的申请，计划从事一种名为 Allesgen 的产品临床试验，他告诉 FDA 并在宣传材料中
表示此药旨在治疗多种癌症。 FDA收到申请后两次通知廖学时，由于提交材料的缺陷，Allesgen 的申请已被完全临床搁置。
FDA要求对该药物粘贴特定标签，说明它是「用于研究的新药，受联邦限制」，廖学时
也曾向FDA表示自己会黏贴这种标签，可事实上，他生产了药物，却在瓶身上标记 「营养补充物 」（supplement） ，并添加一个标签，称其 「不是一种药物，未经FDA评估，不能用于治疗任何疾病。」
从2012年7月到2018年1月的六年里，廖学时以每瓶 2000元的价格销售Allesgen给各州
和国外的客户，他至少获得总计约161万5000元的收入。
陪审团认为，廖学时没有告知对方这是一种未获批准的癌症治疗药物，禁止销售，并可能会产生不可预测且严重的副作用。几名 Allesgen买家在审判期间作证，表示他们并
不知道这些信息。
这是美国版的我是药神吧，被镇压了
胆子很大嘛，IND都被拒了，很可能就是老鼠数据有安全问题。
有很多是专利问题，比方说osimertinib是三代肺癌药，但其实还有一个药WZ4002也是
三代药，没被FDA批准，但是中国国内有人做也有人吃这个药。
这里面水深了去了。
【 在 wwwhu (fc) 的大作中提到: 】
: 胆子很大嘛，IND都被拒了，很可能就是老鼠数据有安全问题。
WZ4002好像临床实验都没咋做完。
肺癌靶向藥WZ4002親身體驗
2017-06-23 由 五彩生活斑斕世界 發表于健康
第一篇文章介紹過WZ4002的前世今生，今天來聊一聊我自己使用這個藥的一些方法和想法。
我的輪換靶向藥是從今年一月份開始，半年輪換過來，肺部腫瘤縮小，血液指標全部正常，CEA（癌胚抗原）控制在3左右（正常值是5以下）。身體倍棒，吃嘛嘛香，睡眠也
很好。
可以說，生病兩年多，這是我最舒服的一段時間。
輪換過程中，連續用過三個月的4002，分別是第一個月單藥4002，第二個月4002連易瑞沙，第三個月4002連特羅凱。總體來說病情控制的不錯，剛開始髖骨轉移都有所緩解。算是效果中等偏上的藥，沒有太好的效果，但是對病人來說可以穩定住那也是相當滿意的。
而且此藥副作用小，沒有腹瀉沒有皮疹，但有一定的心臟毒性，服用期間可以加上輔酶Q10保護心臟。
什麼時候上4002呢，個人認為在一代藥耐藥之後，確定有T790M突變的情況下，此時可
以考慮使用4002，但是連藥或者不連藥，這個是仁者見仁智者見智的選擇，EGFR靶點已經被打壓的夠嗆，是否還繼續用4002聯合一代藥繼續打壓，還是單用4002給以喘息機會，都是個人選擇，並無標準可言。我開始只用單藥4002一個月，之後兩個月才連上一代藥，也是出於不要趕盡殺絕的想法。至於科不科學，正不正確，那應該是誰用誰知道，沒有標準可言。畢竟肺癌這個病個體差異性不小，所以無法生搬硬套。尋求適合自己的方法才是長久生存之計。
我想沒有哪個藥物研發團隊研發藥物的目的是配合其他藥聯合使用，所以理論上單藥也會有相應的效果，但是不能否認很多時候聯藥效果更佳。就像卡博替尼（XL184），絕
大多數病人是聯藥使用，我單吃了一個月效果也是很好的。當然這只是個例，不具備廣譜性。
以上文字，全都是個人治療主觀想法。歡迎交流。
不喜勿噴，謝謝看官老爺。
原文網址：https://kknews.cc/health/29ge64e.html
廖博士就是因为卖这个药被判了100多年
【 在 wwwhu (fc) 的大作中提到: 】
: 胆子很大嘛，IND都被拒了，很可能就是老鼠数据有安全问题。
听你这个真博士后的话，真的要赔掉几个张天爱。WZ4002是第一个EGFR mutation抑制
剂,dana-farber做的，开启了嘧啶类抑制EGFR突变的思路，开天辟地有什么专利问题？后面做得好的，都是受它启发，要说专利问题，反而是后来居上的好东西才有。它没人做clinical trials是因为就是没人愿意做。中国做第三代的很多，甚至有反向向美国
公司转让的例子了，比如海归钱向平就把非亚洲的市场卖给CKPT开发,中国RX518，美国CK-101。谁还会废上几亿块钱弄肯定卖不了货的最早第一个，情怀？只要是好东西，就不担心专利费。你是博士后，不是阴谋家啊，先生。
【 在 lubbock12 (非老非小将) 的大作中提到: 】
: 有很多是专利问题，比方说osimertinib是三代肺癌药，但其实还有一个药WZ4002也是
: 三代药，没被FDA批准，但是中国国内有人做也有人吃这个药。
: 这里面水深了去了。
Pasi A. Jänne的组因为WZ4OO2专利冲突，导致该药最终没能上市。
【 在 wwwhu (fc) 的大作中提到: 】
: 听你这个真博士后的话，真的要赔掉几个张天爱。WZ4002是第一个EGFR mutation抑制
: 剂,dana-farber做的，开启了嘧啶类抑制EGFR突变的思路，开天辟地有什么专利问题？
: 后面做得好的，都是受它启发，要说专利问题，反而是后来居上的好东西才有。它没人
: 做clinical trials是因为就是没人愿意做。中国做第三代的很多，甚至有反向向美国
: 公司转让的例子了，比如海归钱向平就把非亚洲的市场卖给CKPT开发,中国RX518，美国
: CK-101。谁还会废上几亿块钱弄肯定卖不了货的最早第一个，情怀？只要是好东西，就
: 不担心专利费。你是博士后，不是阴谋家啊，先生。
你对上市有什么误解吧？一个compound,pre-clinical做完，file IND, 再做phaseI,II,III, file NDA,批准了，才能上市。pre-clinical都没做完，上什么市？专利对于开
发商，从来不是问题，问题是潜力。上$B的钱砸进去，single digit x%的销量提成，
孰重孰轻？
【 在 lubbock12 (非老非小将) 的大作中提到: 】
: Pasi A. Jänne的组因为WZ4OO2专利冲突，导致该药最终没能上市。
有上市可能，才有人掏钱给你做临床实验。
【 在 wwwhu (fc) 的大作中提到: 】
: 你对上市有什么误解吧？一个compound,pre-clinical做完，file IND, 再做phaseI,II
: ,III, file NDA,批准了，才能上市。pre-clinical都没做完，上什么市？专利对于开
: 发商，从来不是问题，问题是潜力。上$B的钱砸进去，single digit x%的销量提成，
: 孰重孰轻？
meanwhile，毒死50万霉帝屁民的Purdue Pharma的Sacklers家族免法律责任http://www.fox61.com/article/news/nation-world/purdue-pharmas-opioid-settlement-plan/507-137b600c-134f-4ff6-bacf-b8af93c09f57
我这里有个详细的报道，WZ4002很好的药，结果死在诺华制药和Dana Farber 专利之争了，Dana Farber认为这药是我发现的，诺华这药研究我赞助的专利归我。
Fighting over molecules
By Steven Syre
Globe Columnist / January 11, 2011
Some fights start over the smallest things. This one is about a molecule
called WZ4002.
There is no shortage of people and powerful organizations fighting over the molecule, discovered by Boston scientists at the Dana-Farber Cancer
Institute; it could be worth a fortune as a new treatment for many lung
cancer patients.
Then again, WZ4002 could turn out to be a big nothing. It’s too early to
tell.
But no one is waiting around to find out, and recent lawsuits offer a rare
public glimpse of a fight over medicine and money that usually takes place
behind closed doors.
Drug giant Novartis International Pharmaceutical Ltd. is locking horns with the scientists who discovered WZ4002. Those researchers are at odds with the president of the company they formed to represent their commercial
interests. Dana-Farber is caught awkwardly in the middle, with important
interests of its own at stake.
The conflict is remarkable because the molecule is nowhere close to becoming an approved drug. It has not been the subject of a single clinical trial.
It’s still a compound in a lab, not a therapy.
John Mirick, a lawyer for researcher Nathanael Gray and three other Dana-
Farber scientists behind WZ4002, says development of the molecule has been
treading water since the licensing dispute broke out last year.
That would be bad news for patients, the real people at the heart of this
story. Jamie Gorenberg has paid close attention to the development of WZ4002 because her mother, Caren Gorenberg, suffers from advanced lung cancer. She recognizes it’s a long shot but hopes the molecule might help her mother
in a clinical trial someday soon.
“I know that’s a big if, but we live on ifs,’’ says Gorenberg. “That’s better than nothing, and I’m going to grab onto it.’’
Gorenberg learned about WZ4002 by reading an article in the scientific
journal Nature in December 2009 that described how the molecule could help
patients with non-small cell lung cancer who also have common gene mutations. Those mutations help the cancer resist the leading treatments, and WZ4002 might get around that problem.
The article in Nature also came as news to executives at Novartis, which
spends more than $15 million a year on sponsored research at Dana-Farber,
according to court papers. The drug company funded some work in Gray’s lab, and executives soon pressed Dana-Farber for rights to WZ4002. Their view:
Novartis owned those commercial rights.
That was a big problem because Dana-Farber gave an option for the rights to Gatekeeper Pharmaceuticals Inc., a company formed by Gray and his colleagues. The cancer institute filed a patent application for WZ4002 but was stuck
between the commercial interests of its scientists and a big research
sponsor.
Dana-Farber’s solution: Sue and let US District Judge David Woodlock decide who owns what.
“We are not seeking any monetary award,’’ Dana-Farber said in a statement yesterday. “We are simply asking the court to determine which of the two
parties has the superior rights to the technology.’’
Meanwhile, the scientists who formed Gatekeeper didn’t see eye to eye with John Chant, whom they hired to run the company and advance the commercial
interests of WZ4002.
Chant didn’t like the company’s legal strategy. He made the ambitious
argument that Gatekeeper’s founders, who owned 87 percent of the company
and constituted its board, were conflicted in the case because they worked
at Dana-Farber, among other reasons.
Chant wants to intervene on behalf of Gatekeeper and pursue another legal
strategy.
Gray and his colleagues say they are open to a settlement with both Novartis and Dana-Farber. Chant wanted to fight for damages and insisted any
settlement must include $750,000 to cover deferred and future compensation
for him, according to court papers filed by the scientists.
“The board concluded Mr. Chant was primarily concerned for his salary and
benefits,’’ they said in the documents.
Strange fact: Chant is still employed by Gatekeeper.
Chant’s lawyer did not return a call yesterday.
Now the judge has to figure it all out or push for a settlement. But time
matters.
“All I can say is, move quickly,’’ Gorenberg says. “I’m not trying to
blame anyone or point fingers.’’
The molecule in question may save lives, though the odds are long. But no
one will figure that out until everyone agrees on who owns WZ4002.
【 在 wwwhu (fc) 的大作中提到: 】
: 听你这个真博士后的话，真的要赔掉几个张天爱。WZ4002是第一个EGFR mutation抑制
: 剂,dana-farber做的，开启了嘧啶类抑制EGFR突变的思路，开天辟地有什么专利问题？
: 后面做得好的，都是受它启发，要说专利问题，反而是后来居上的好东西才有。它没人
: 做clinical trials是因为就是没人愿意做。中国做第三代的很多，甚至有反向向美国
: 公司转让的例子了，比如海归钱向平就把非亚洲的市场卖给CKPT开发,中国RX518，美国
: CK-101。谁还会废上几亿块钱弄肯定卖不了货的最早第一个，情怀？只要是好东西，就
: 不担心专利费。你是博士后，不是阴谋家啊，先生。
这种小专利官司，大公司一年没有100个也有20个。重要的是10年后大家依然没有兴趣
做完pre-clinical，tagrisso(osimertinib)都卖了几十亿了吧, 发明人royalty拿到手软了吧。
【 在 lubbock12 (非老非小将) 的大作中提到: 】
: 我这里有个详细的报道，WZ4002很好的药，结果死在诺华制药和Dana Farber 专利之争
: 了，Dana Farber认为这药是我发现的，诺华这药研究我赞助的专利归我。
: Fighting over molecules
: By Steven Syre
: Globe Columnist / January 11, 2011
: Some fights start over the smallest things. This one is about a molecule
: called WZ4002.
: There is no shortage of people and powerful organizations fighting over
the
: molecule, discovered by Boston scientists at the Dana-Farber Cancer
: Institute; it could be worth a fortune as a new treatment for many lung
: ...................
我怎么觉得你就是不懂装懂呢
【 在 wwwhu (fc) 的大作中提到: 】
: 这种小专利官司，大公司一年没有100个也有20个。重要的是10年后大家依然没有兴趣
: 做完pre-clinical，tagrisso(osimertinib)都卖了几十亿了吧, 发明人royalty拿到手
: 软了吧。
: the
挺惨的，为了区区 160 万美元， 就犯这么大的罪
太不值了
【 在 lubbock12 (非老非小将) 的大作中提到: 】
: 美国联邦检察官办公室近日宣布，定居南加橙县富乐顿的华裔医生廖学时（Benedict
: Liao）在六年期间，以欺诈手段销售未经批准的癌症治疗药物，共牟取超过161万元的
: 非法收入，他被指控的26项重罪，日前经由陪审团裁定均成立，最高恐面临197年监禁
: 。该案已订2022年2月14日举行量刑听证会。
: 81岁的廖学时又名Wada Masao和Masao A. Wada，他面临的26项重罪指控，包括七项电
: 汇欺诈，11项销售贴错标签的药物，八项销售未经批准的新药，11月2日陪审团裁定这
: 些控罪都成立。
: 根据廖学时在为期五天的审判中提供的证据，他经营一家名为Oeyama-Moto的癌症研究
: 基金会，该基金会在蒙特利公园市（Monterey Park）、西柯汶那市（West Covina）先
: 后设有办事处。
: ...................
他都80了。美国法院估计就是吓唬吓唬他，这么老的人美国监狱都不愿意收的。
【 在 ts78 (ts) 的大作中提到: 】
: 挺惨的，为了区区 160 万美元， 就犯这么大的罪
: 太不值了
来军版不就是想不懂也装个逼嘛。
小伙子，我们要在杀老鼠之余，关注一下行当的上下游八卦。我一个中文系转码都知道要关注生物医学行业。
【 在 lubbock12 (非老非小将) 的大作中提到: 】
: 我怎么觉得你就是不懂装懂呢