LAM group — Competitive Intelligence Brief

LAM group (LAM group) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: mTOR inhibitor. Area: Rare Pulmonary/Oncology.

phase 3 mTOR inhibitor mTOR Rare Pulmonary/Oncology Small molecule

Target snapshot

LAM group (LAM group) — GlaxoSmithKline. LAM group refers to a class of compounds targeting lymphangioleiomyomatosis-related pathways, likely inhibiting mTOR signaling to reduce abnormal smooth muscle cell proliferation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
LAM group TARGET	LAM group	GlaxoSmithKline	phase 3	mTOR inhibitor	mTOR
Afinitor	everolimus	Novartis	marketed	Kinase Inhibitor [EPC]	Serine/threonine-protein kinase mTOR	2009-01-01
Torisel	temsirolimus	Pfizer	marketed	Kinase Inhibitor	Serine/threonine-protein kinase mTOR	2007-01-01
SIROLIMUS	SIROLIMUS		marketed	mTOR Inhibitor Immunosuppressant [EPC]	mTOR	1999-01-01
Rapamune	sirolimus	Pfizer	marketed	mTOR Inhibitor Immunosuppressant [EPC]	Serine/threonine-protein kinase mTOR	1999-01-01
Conversion from Tacrolimus to Sirolimus	Conversion from Tacrolimus to Sirolimus	Helio Tedesco Silva Junior	marketed	Immunosuppressive agent (conversion protocol)	mTOR (mammalian target of rapamycin)
CsA+Rapamune+CS	CsA+Rapamune+CS	Pfizer	marketed	Immunosuppressive combination therapy	Calcineurin, mTOR, glucocorticoid receptor

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2028-07-01 — Afinitor · 9006224 · Method of Use · US
• 2029-02-14 — Rapamune · 8911786 · Formulation · US
• 2030-04-15 — Rapamune · 10206887 · Formulation · US
• 2036-03-05 — Rapamune · 12061183 · Formulation · US
• 2036-03-05 — Rapamune · 10705070 · Formulation · US
• 2036-06-29 — Rapamune · 10973806 · Method of Use · US
• 2036-06-29 — Rapamune · 12133844 · Method of Use · US
• 2040-10-28 — Rapamune · 11497737 · Formulation · US

Sponsor landscape (mTOR inhibitor class)

1. Chong Kun Dang Pharmaceutical · 2 drugs in this class
2. Wyeth is now a wholly owned subsidiary of Pfizer · 2 drugs in this class
3. Exelixis · 1 drug in this class
4. GlaxoSmithKline · 1 drug in this class
5. Grupo Espanol de Tumores Neuroendocrinos · 1 drug in this class
6. H. Lee Moffitt Cancer Center and Research Institute · 1 drug in this class
7. Hannover Medical School · 1 drug in this class
8. Hospital do Rim e Hipertensão · 1 drug in this class
9. ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · 1 drug in this class
10. Melanoma and Skin Cancer Trials Limited · 1 drug in this class